Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-19 @ 11:19 PM
Study NCT ID:
NCT05647057
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2022-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPB Prime Fluid Strategies to Preserve Mcirocirculatory Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006461', 'term': 'Hemolysis'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-25', 'size': 131860, 'label': 'Study Protocol: Explanation of Randomization process', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-26T03:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In two consecutive randomized controlled trials, the investigators study the effect of prime fluid strategies on perfused vessel density (part I) and the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density (part II).\n\nIn this study part (I), the effect of prime fluid strategies on perfused vessel density.\n\nA single centre, double-blind randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-11-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'Preoperative', 'description': 'Age in years'}, {'measure': 'Gender', 'timeFrame': 'Preoperative', 'description': 'Gender (male/female)'}, {'measure': 'Body Surface Area (BSA)', 'timeFrame': 'Preoperative', 'description': 'BSA in m2'}, {'measure': 'Smoking', 'timeFrame': 'Preoperative', 'description': 'Medical history of smoking (yes/no)'}, {'measure': 'Diabetes on medication', 'timeFrame': 'Preoperative', 'description': 'Medical history of diabetes on medication (yes/no)'}, {'measure': 'Comorbidities', 'timeFrame': 'Preoperative', 'description': 'Other comorbidities in medical history (yes/no)'}, {'measure': 'EuroSCORE II', 'timeFrame': 'Preoperative', 'description': 'The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II predicts risk of in-hospital mortality after cardiac surgery.'}, {'measure': 'CPB time (min)', 'timeFrame': 'intraoperative', 'description': 'Cardiopulmonary bypass time in minutes'}, {'measure': 'Aortic cross clamping time (AoX time, min)', 'timeFrame': 'intraoperative', 'description': 'Aortic cross clamping time in minutes'}, {'measure': 'heparin (IU)', 'timeFrame': 'intraoperative', 'description': 'Dosing of heparin in international units'}, {'measure': 'protamin (mg)', 'timeFrame': 'intraoperative', 'description': 'dosing of protamin'}, {'measure': 'Activated Clotting Time (ACT, min)', 'timeFrame': 'intraoperative', 'description': 'ACT in minutes'}, {'measure': 'Temperature (celsius)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Temperature in celsius'}, {'measure': 'Oxygen saturation (Sat, %)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Oxygen saturation in %'}, {'measure': 'Urine production (ml)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Urine production'}, {'measure': 'Blood pressure (mmHg)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Blood pressure (mmHg)'}, {'measure': 'Noradrenaline infusion', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Noradrenaline infusion (mcg/kg/min)'}, {'measure': 'Phenylephrine', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Phenylephrine (mcg)'}, {'measure': 'Vasopressin (IU/min)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Vasopressin (IU/min)'}, {'measure': 'Methylene Blue (mg)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Methylene blue (mg)'}, {'measure': 'Lactate (mmol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Serum lactate'}, {'measure': 'Creatinin levels (umol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'serum creatinin level'}, {'measure': 'estimated glomerular filtration rate (eGFR, ml/min/1,73 m2)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'estimated glomerular filtration rate'}, {'measure': 'Blood product use', 'timeFrame': 'Intraoperative and up to 24 hours postoperative', 'description': 'Blood product use (ml)'}, {'measure': 'Blood loss (ml)', 'timeFrame': 'T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit', 'description': 'Blood loss'}, {'measure': 'Duration of mechanical ventilation (hours)', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'Duration of mechanical ventilation (hours)'}, {'measure': 'ICU stay (hours)', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'ICU stay (hours)'}, {'measure': 'Hospital stay (days)', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'Days until hospital discharge (days)'}, {'measure': 'Acute Kidney injury (AKI)', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'Acute kidney injury (yes/no)'}, {'measure': 'Respiratory failure', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'Respiratory failure (yes/no)'}, {'measure': 'Pneumonia', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'Pneumonia (yes/no)'}, {'measure': 'non-preexisting atrial fibrillation', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'non-preexisting atrial fibrillation (yes/no)'}, {'measure': 're-do surgery', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 're-do surgery (yes/no)'}, {'measure': 'Extra corporeal membrane oxygenation (ECMO)', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'Extra corporeal membrane oxygenation (yes/no)'}, {'measure': 'Mortality', 'timeFrame': 'Postoperative until 30 days postoperative', 'description': 'In-hospital mortality (yes/no)'}, {'measure': 'Sodium (mmol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Serum sodium'}, {'measure': 'Potassium (mmol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Serum potassium'}, {'measure': 'Calcium (mmol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Serum calcium'}, {'measure': 'Chloride (mmol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Serum chloride'}, {'measure': 'Bicarbonate (mmol/L)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Serum bicarbonate'}, {'measure': 'CO2 (kPa)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Carbon dioxide pressure in plasma'}, {'measure': 'O2 (kPa)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Oxygen pressure in plasma'}, {'measure': 'pH', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Measurement of hydrogen ions in plasma'}], 'primaryOutcomes': [{'measure': 'Perfused vessel density (PVD, mm mm-²)', 'timeFrame': 'T1: within 5-10 minutes after induction of anesthesia', 'description': 'reflecting microcirculatory diffusion capacity'}, {'measure': 'Perfused vessel density (PVD, mm mm-²)', 'timeFrame': 'T2 within 5-10 minutes after aortic cross clamping', 'description': 'reflecting microcirculatory diffusion capacity'}, {'measure': 'Perfused vessel density (PVD, mm mm-²)', 'timeFrame': 'T3 within 5-10 minutes after weaning from cardiopulmonary bypass', 'description': 'reflecting microcirculatory diffusion capacity'}, {'measure': 'Perfused vessel density (PVD, mm mm-²)', 'timeFrame': 'T4 within 15-30 min after arrival on the intensive care unit', 'description': 'reflecting microcirculatory diffusion capacity'}, {'measure': 'Perfused vessel density (PVD, mm mm-²)', 'timeFrame': 'T5 twenty four (24) hours after arrival on the intensive care unit', 'description': 'reflecting microcirculatory diffusion capacity'}], 'secondaryOutcomes': [{'measure': 'Colloid oncotic pressure (COP, mmHg)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'colloid oncotic pressure in plasma'}, {'measure': 'albumin (g L-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'concentration of albumin in plasma'}, {'measure': 'hemolysis index (H-index)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'the grade of hemolysis in plasma'}, {'measure': 'haptoglobin (g L-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'concentration of haptoglobin in plasma'}, {'measure': 'syndecan-1 (ng/ml)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Concentration of syndecan-1 in plasma'}, {'measure': 'heparan sulphate (ng/ml)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'concentration of heparan sulphate in plasma'}, {'measure': 'hemoglobin (Hb, mmol L-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'concentration of hemoglobin in serum'}, {'measure': 'hematocrit (Ht, L L-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'hematocrit in serum'}, {'measure': 'perioperative use of packed red blood cells (PRBCs, mL)', 'timeFrame': 'Intraoperative during cardiac surgery, postoperative period up to 24 hours postoperative', 'description': 'amount of packed red blood cells'}, {'measure': 'fluid balance (mL)', 'timeFrame': 'Intraoperative during cardiac surgery, postoperative period up to 24 hours postoperative', 'description': 'fluid balance'}, {'measure': 'fluid requirements (mL)', 'timeFrame': 'Intraoperative during cardiac surgery, postoperative period up to 24 hours postoperative', 'description': 'Amount of fluids required'}, {'measure': 'Total vessel density (TVD, mm mm-²)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'density of capillaries reflecting the functional state of the microcirculatory diffusion capacity'}, {'measure': 'Proportion of perfused vessels (PPV, %)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'reflecting the aspect of heterogeneity of microcirculatory perfusion'}, {'measure': 'Heterogeneity index', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'reflecting the aspect of heterogeneity of microcirculatory perfusion'}, {'measure': 'Thrombomodulin (ng mL-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Thrombomodulin concentration in plasma'}, {'measure': 'Angiopoietin-2 (ng mL-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Angiopoietin-2 concentration in plasma'}, {'measure': 'Interleukin-6 (ng mL-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Interleukin-6 concentration in plasma'}, {'measure': 'Tumor necrosis factor (TNF-alpha, ng mL-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'TNF-alpha concentration in plasma'}, {'measure': 'Neutrophil gelatinase associated lipocalin (NGAL, ng mL-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'NGAL concentration in plasma'}, {'measure': 'Magnesium (mmol L-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Magnesium concentration in plasma'}, {'measure': 'Phosphate (mmol L-¹)', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Phosphate concentration in plasma'}, {'measure': 'Oxygen delivery (mL min-¹)', 'timeFrame': 'During cardiopulmonary bypass', 'description': 'Oxygen delivery'}, {'measure': 'Microvascular Flow Index', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'Microvascular Flow Index, semi-quantitative assessment of the average red blood cell velocity per quadrant'}, {'measure': 'De Backer-score', 'timeFrame': 'T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.', 'description': 'De Backer-score, proxy of total vessel density'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microcirculation', 'Cardiopulmonary bypass', 'Colloid oncotic pressure', 'Hemodilution', 'Hemolysis'], 'conditions': ['Endothelial Dysfunction', 'Hemolysis', 'Fluid Overload']}, 'referencesModule': {'references': [{'pmid': '38532434', 'type': 'DERIVED', 'citation': 'Beukers AM, Bulte CSE, Bosch RJ, Eberl S, van den Brom CE, Loer SA, Vonk ABA. Optimization of cardiopulmonary bypass prime fluid to preserve microcirculatory perfusion during on-pump coronary artery bypass graft surgery: PRIME study protocol for a double-blind randomized trial. Trials. 2024 Mar 26;25(1):219. doi: 10.1186/s13063-024-08053-5.'}]}, 'descriptionModule': {'briefSummary': "Acute microcirculatory perfusion disturbances is common in critical illness and associated with higher morbidity and mortality. Recent findings by the investigators' group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours after surgery. A cardiopulmonary bypass is a machine which takes over heart and lung function, during the procedure. The disturbed microcirculation is associated with organ dysfunction induced by cardiac surgery using CPB, which is frequently seen (up to 42%, forty two percent) and results in a six-fold increase in mortality rate. The underlying cause of disturbed microcirculation is a higher endothelial permeability and vascular leakage and are a consequence of systemic inflammation, hemodilution (dilution of blood), hypothermia and hemolysis (breakdown of red blood cells). To gain the knowledge regarding disturbed microcirculation the investigators previously showed that hemodilution attributes to this disturbed perfusion. Hemodilution lowers colloid oncotic pressure (COP). Also, COP is affected by free hemoglobin, which increases with hemolysis and attributes to a disturbed microcirculation following CPB. This is interesting, as to the best of our knowledge, the effect of minimizing hemodilution and hemolysis during cardiac surgery on the microcirculatory perfusion has never been investigated, but could be the key factor in reducing organ dysfunction.", 'detailedDescription': 'In this project the investigators focus on reducing microcirculatory perfusion disturbances by exploring therapeutic approaches with different prime fluid strategies, by acting on COP (part I) and free hemoglobin scavenging with human albumin (part II).\n\nIn part I, patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass will be randomized in three groups receiving different prime fluid strategies. The study endpoint is the reduction in functional capillary density during the perioperative period. Sublingual microcirculatory measurements and blood sampling will take place after induction of anesthesia, during and after surgery to determine microcirculatory perfusion and parameters for hemodilution, hemolysis, COP, markers for endothelial damage and glycocalyx shedding. Measurements start on the day of surgery and end one day after surgery.\n\nIn part II, participants will be randomized in two groups receiving the first dose directly after aortic cross clamping and blood cardioplegia administration, and the second dose after the third blood cardioplegia administration (± 30 min after the first dose).The most optimal prime fluid in order to preserve microcirculatory perfusion from study one, will be used as prime fluid in the second study. Microcirculatory perfusion parameters will be measured at time points comparable with study one. Blood samples are taken to determine markers for hemodilution, hemolysis, COP and endothelial damage and glycocalyx shedding. For part II see trial registration: PRIME, part II.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects\n* Informed consent\n* Elective coronary artery bypass surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Emergency operations\n* Re-operation\n* Elective thoracic aortic surgery\n* Elective valve surgery\n* The use of crystalloid cardioplegia\n* Combined procedure CABG and valve surgery\n* Known allergy for human albumin or gelofusine'}, 'identificationModule': {'nctId': 'NCT05647057', 'acronym': 'PRIME', 'briefTitle': 'CPB Prime Fluid Strategies to Preserve Mcirocirculatory Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'NL82500.029.22, part I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: gelofusine + ringers', 'description': 'Prime fluid strategy containing gelofusine and ringers', 'interventionNames': ['Combination Product: A: gelofusine + ringers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: albumin + ringers', 'description': 'Prime fluid strategy containing albumin and ringers', 'interventionNames': ['Combination Product: B: albumine + ringers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C: ringers + retrograde autologous priming', 'description': 'Prime fluid strategy containing ringers combined with retrograde autologous priming', 'interventionNames': ['Combination Product: C: ringers + retrograde autologous priming']}], 'interventions': [{'name': 'A: gelofusine + ringers', 'type': 'COMBINATION_PRODUCT', 'description': "750 milliliter (mL) modified fluid gelatin (Braun Melsungen, Germany), 650 mL Ringer's solution (Baxter, Utrecht, Netherlands) and 100 mL mannitol (15%, Baxter, Utrecht, Netherlands)", 'armGroupLabels': ['A: gelofusine + ringers']}, {'name': 'B: albumine + ringers', 'type': 'COMBINATION_PRODUCT', 'description': "200 mL human albumin (20%, Sanquin, Amsterdam, Netherlands), 1200 mL Ringer's solution (Baxter, Utrecht, Netherlands) and 100 mL mannitol (15%, Baxter, Utrecht, Netherlands)", 'armGroupLabels': ['B: albumin + ringers']}, {'name': 'C: ringers + retrograde autologous priming', 'type': 'COMBINATION_PRODUCT', 'description': "1400 mL Ringer's solution (Baxter, Utrecht, Netherlands) and 100 mL mannitol (15%, Baxter, Utrecht, Netherlands) with retrograde autologous priming.\n\nRetrograde autologous priming (RAP) is applied using clinical parameters such as Central Venous Pressure, Mean Arterial Pressure (MAP), and intra cardiac filling pressure based on Trans Esophageal Echo as guidance to the amount of fluid displaced. RAP is applied to a maximum volume of 475 mL provided that systolic blood pressure will remain \\>90 millimeter of mercury (mmHg). Phenylephrine can be administered up to 200 mcg to keep the system hemodynamics stable during RAP. In case of a body surface area \\<1.7m2, a maximum volume of 375 mL is desired. Once the desired amount of prime is displaced, the transfusion bag is clamped and CPB is started. If additional fluids are needed during CPB to maintain optimal perfusion, the displaced prime is used prior to the vasoplegia protocol.", 'armGroupLabels': ['C: ringers + retrograde autologous priming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, AMC location', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'A.B.A. Vonk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiothoracic surgeon'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Upon request', 'ipdSharing': 'YES', 'description': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiothoracic surgeon, Principle Investigator, doctor.', 'investigatorFullName': 'Alexander B.A. Vonk', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}