Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-29 @ 9:51 AM
Study NCT ID:
NCT02782520
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D006982', 'term': 'Hypertonic Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right ventricular ejection fraction change measured by Swan Ganz catheter.', 'timeFrame': 'after 30 minutes perfusion ( fluid expansion)'}], 'secondaryOutcomes': [{'measure': 'Left ventricular contractility', 'timeFrame': 'at 30, 60 minutes and 3, 6 and 18 hours after perfusion'}, {'measure': 'Systolic volume change', 'timeFrame': 'at 30, 60 minutes and 3, 6 and 18 hours after perfusion'}, {'measure': 'Cardiac output evolution.', 'timeFrame': 'at 30, 60 minutes and 3, 6 and 18 hours after perfusion'}, {'measure': 'Tricuspid annular plane systolic excursion assessment', 'timeFrame': 'One hour before and after perfusion'}, {'measure': 'Continuous cardiac output', 'timeFrame': 'at 30, 60 minutes and 3, 6 and 18 hours after perfusion'}, {'measure': 'Blood volume efficiency', 'timeFrame': 'One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion', 'description': 'Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure'}, {'measure': 'Plasmatic volume monitoring', 'timeFrame': 'One hour before and , 1, 6 and 18 hours after perfusion', 'description': 'Plasmatic volume augmentation assessed by hemoglobin decrease'}, {'measure': 'Natremia level', 'timeFrame': 'at 1, 6 and 18 hours after perfusion'}, {'measure': 'Veinous oxygen saturation', 'timeFrame': 'at 30, 60 minutes and 3, 6 and 18 hours after perfusion'}, {'measure': 'Mean arterial pressure assessment.', 'timeFrame': 'at 30, 60 minutes and 3, 6 and 18 hours after perfusion'}, {'measure': 'Lactatemia level', 'timeFrame': 'at 1, 6 and 18 hours after perfusion'}, {'measure': 'Acid base balance assessment.', 'timeFrame': 'at 1, 6 and 18 hours after perfusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass', 'Swan Ganz', 'Fluid expansion', 'hypertonic saline solution'], 'conditions': ['Right Ventricular Impaired Function', 'Hypovolemia']}, 'referencesModule': {'references': [{'pmid': '10661697', 'type': 'BACKGROUND', 'citation': 'Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1016/s0967-2109(99)00089-7.'}, {'pmid': '9257260', 'type': 'BACKGROUND', 'citation': 'Gavazzi A, Berzuini C, Campana C, Inserra C, Ponzetta M, Sebastiani R, Ghio S, Recusani F. Value of right ventricular ejection fraction in predicting short-term prognosis of patients with severe chronic heart failure. J Heart Lung Transplant. 1997 Jul;16(7):774-85.'}, {'pmid': '3875003', 'type': 'BACKGROUND', 'citation': 'Christakis GT, Fremes SE, Weisel RD, Ivanov J, Madonik MM, Seawright SJ, McLaughlin PR. Right ventricular dysfunction following cold potassium cardioplegia. J Thorac Cardiovasc Surg. 1985 Aug;90(2):243-50.'}, {'pmid': '16426341', 'type': 'BACKGROUND', 'citation': 'Durand M, Chavanon O, Tessier Y, Casez M, Gardellin M, Blin D, Girardet P. Right ventricular function after coronary surgery with or without bypass. J Card Surg. 2006 Jan-Feb;21(1):11-6. doi: 10.1111/j.1540-8191.2006.00161.x.'}, {'pmid': '7574010', 'type': 'BACKGROUND', 'citation': 'Mouren S, Delayance S, Mion G, Souktani R, Fellahi JL, Arthaud M, Baron JF, Viars P. Mechanisms of increased myocardial contractility with hypertonic saline solutions in isolated blood-perfused rabbit hearts. Anesth Analg. 1995 Oct;81(4):777-82. doi: 10.1097/00000539-199510000-00021.'}, {'pmid': '12181215', 'type': 'BACKGROUND', 'citation': 'Ueti OM, Camargo EE, Ueti Ade A, de Lima-Filho EC, Nogueira EA. Assessment of right ventricular function with Doppler echocardiographic indices derived from tricuspid annular motion: comparison with radionuclide angiography. Heart. 2002 Sep;88(3):244-8. doi: 10.1136/heart.88.3.244.'}, {'pmid': '2036225', 'type': 'BACKGROUND', 'citation': 'Hammarstrom E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9. doi: 10.1016/s0894-7317(14)80524-5.'}, {'pmid': '22197117', 'type': 'BACKGROUND', 'citation': 'Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.'}, {'pmid': '23474659', 'type': 'BACKGROUND', 'citation': 'Scolletta S, Bodson L, Donadello K, Taccone FS, Devigili A, Vincent JL, De Backer D. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med. 2013 Jun;39(6):1025-33. doi: 10.1007/s00134-013-2861-8. Epub 2013 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.\n\nAdults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.\n\nPatients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).\n\nRight ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective valvular or coronary surgery\n* Under cardiopulmonary bypass\n* Patient requiring Swan Ganz catheter monitoring\n* Patient in sinus rhythm\n* Patient requiring post-operative volemic expansion\n* Echographic criteria of hypovolemia, without hypervolemia\n\nExclusion Criteria:\n\n* Pulmonary hypertension (SPAP \\> 60mmHg)\n* No pre-operative sinus rhythm\n* Emergency surgery\n* Age \\< 18 years\n* Chronic renal failure treated with dialysis\n* Severe hypernatremia'}, 'identificationModule': {'nctId': 'NCT02782520', 'acronym': 'SUCCESS', 'briefTitle': 'Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery', 'orgStudyIdInfo': {'id': '38RC15.214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ringer Lactate', 'description': 'Ringer Lactate group', 'interventionNames': ['Drug: Ringer Lactate (10ml/kg) fluid expansion']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertonic saline', 'description': 'Hypertonic saline group', 'interventionNames': ['Drug: Hypertonic saline (3ml/kg) fluid expansion']}], 'interventions': [{'name': 'Ringer Lactate (10ml/kg) fluid expansion', 'type': 'DRUG', 'armGroupLabels': ['Ringer Lactate']}, {'name': 'Hypertonic saline (3ml/kg) fluid expansion', 'type': 'DRUG', 'armGroupLabels': ['Hypertonic saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'La Tronche', 'state': 'Grenoble', 'country': 'France', 'facility': 'Reanimation Cardiovasculaire Et Thoracique', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}