Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT04198168
Status:
TERMINATED
Last Update Posted:
2020-12-09
First Post:
2019-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D006940', 'term': 'Hyperemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in renal function in response to a standardised fluid bolus.', 'timeFrame': '6 hours', 'description': 'Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.'}], 'secondaryOutcomes': [{'measure': 'Renal venous flow classification', 'timeFrame': '6 hours', 'description': 'normal - abnormal (pulsatile/biphasic/monophasic'}, {'measure': 'Renal venous impedance index', 'timeFrame': '6 hours', 'description': '(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity'}, {'measure': 'Renal venous stasis index', 'timeFrame': '6 hours', 'description': '(index cardiac cycle time - venous flow time) / index cardiac cycle time'}, {'measure': 'Renal arterial resistive index', 'timeFrame': '6 hours', 'description': '(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity'}, {'measure': 'Portal venous pulsatility fraction', 'timeFrame': '6 hours', 'description': '(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity'}, {'measure': 'Contrast enhanced ultrasound 1', 'timeFrame': '6 hours', 'description': 'Mean transit time (mTT)'}, {'measure': 'Contrast enhanced ultrasound 2', 'timeFrame': '6 hours', 'description': 'Perfusion Index (PI)'}, {'measure': 'Contrast enhanced ultrasound 3', 'timeFrame': '6 hours', 'description': 'Relative Blood Volume (rBV)'}, {'measure': 'Contrast enhanced ultrasound 4', 'timeFrame': '6 hours', 'description': 'Wash-in Rate (WiR)'}, {'measure': 'Contrast enhanced ultrasound 5', 'timeFrame': '6 hours', 'description': 'Quality Of Fit (QOF)'}, {'measure': 'Continuous recordings of hemodynamic variables 1', 'timeFrame': '6 hours', 'description': 'arterial pressure'}, {'measure': 'Continuous recordings of hemodynamic variables 2', 'timeFrame': '6 hours', 'description': 'Central venous pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Renal perfusion', 'Fluid treatment', 'Venous congestion', 'Renal function'], 'conditions': ['Acute Kidney Injury', 'Hypoperfusion', 'Fluid Overload']}, 'descriptionModule': {'briefSummary': 'The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in glomerular filtration rate (GFR) in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful.', 'detailedDescription': 'The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in GFR in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful.\n\nPatients available for inclusion will receive a baseline administration of Tc-99-DTPA for precise determination of GFR/renal function by blood and urine samples.\n\nBaseline values of ultrasound measures will be obtained, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures and renal contrast enhanced ultrasound (CEUS) will also be recorded.\n\nAfter two hours, baseline values of GFR are finished. The patient is then exposed to passive leg raising and ultrasound measures are repeated, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures.\n\nThe participant then receives a standardised fluid bolus of 7 ml/kg (ideal body weight) Once the fluid bolus administration is complete, renal ultrasound is repeated, including renal arterial, renal venous, portal venous, hepatic venous Doppler measures and renal CEUS.\n\nFollow-up determination of GFR/renal function based on Tc-99-DTPA after fluid therapy is repeated with blood and urine samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the ICU at Aarhus University Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years admitted to the ICU, Aarhus University Hospital.\n* Patients who are assessed by their attending physician as having need for fluid therapy.\n\nExclusion Criteria:\n\n* Insufficient ultrasound imaging of the kidneys.\n* Pregnancy.\n* Intolerance to any ultrasound contrast agent or isotopes, including intolerance for human albumin.\n* Prior enrolment in a conflicting research study.\n* Known morphological kidney disease.\n* Need for dialysis.\n* Need for extracorporeal membrane oxygenation (ECMO).\n* Prior participation.\n* Severe pulmonary hypertension (systolic pulmonary pressure \\> 90 mmHg)'}, 'identificationModule': {'nctId': 'NCT04198168', 'briefTitle': 'The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.', 'orgStudyIdInfo': {'id': '1-10-72-75-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU patients', 'description': 'ICU patients who are assessed by their attending physician as having need for fluid therapy and are planned to receive IV crystalloid fluid due to oliguria and/or to improve GFR.', 'interventionNames': ['Drug: IV crystalloid fluid bolus']}], 'interventions': [{'name': 'IV crystalloid fluid bolus', 'type': 'DRUG', 'description': 'The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).', 'armGroupLabels': ['ICU patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Department of Anaesthesiology', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Johan Fridolf Hermansen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}