Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 12:28 PM
Study NCT ID:
NCT05909150
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2023-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of acute kidney injury', 'timeFrame': 'Days 3 -7 post-transplantation', 'description': 'Demonstrate a peak value of creatinine 30% lower in the active arm'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Incidence of all cause mortality during the first 30 days after start of the study'}, {'measure': 'Incidence of acute kidney injury requiring hemodialysis', 'timeFrame': '30 days', 'description': 'Rate of patients which required hemodialysis during the first 30 days after start of the study'}, {'measure': 'Intensive care unit (ICU) length of stay', 'timeFrame': 'During ICU stay, an average of 5 days', 'description': 'The time frame between start of the study and ICU discharge will be calculated.'}, {'measure': 'Time to wean inotropes and vasopressors', 'timeFrame': 'During ICU stay, an average of 5 days', 'description': 'Time to wean all inotropes and vasopressors will be calculated.'}, {'measure': 'Incidence of right ventricular dysfunction', 'timeFrame': 'Until day 5 post-transplantation', 'description': "Right ventricular dysfunction will be assessed through the following echocardiographic parameters:\n\n* Tricuspid annular plane systolic excursion (TAPSE; normal ≥1.7 cm);\n* Tricuspid annular velocity (S') (normal ≥9.5 cm/s);\n* Fractional area change (FAC; normal ≥35 percent);\n* Right Ventricle basal diameter (normal ≤4.1 cm)"}, {'measure': 'Hypertonic saline solution (HSS) hemodynamic effect', 'timeFrame': 'Until day 3 post-transplantation', 'description': 'Pulmonary artery catheter measures will be assessed before HSS infusion, immediately after HSS infusion and 30 min after HSS infusion.\n\nThe following measures will be assessed:\n\n* Right atrial pressure (RAP)\n* Systolic pulmonary artery pressure (sPAP)\n* Diastolic pulmonary artery pressure (dPAP)\n* Mean pulmonary artery pressure (mPAP)\n* Pulmonary artery wedge pressure (PCWP)\n* Cardiac output (CO)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Transplantation', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.', 'detailedDescription': 'Acute kidney injury (AKI) is a frequent complication immediately after heart transplantation (HT), with incidence rates between 40-70%. Several factors contribute to this complication, such as hypervolemia, hyperactivation of renin-angiotensin-aldosterone system (RASS) and low cardiac output. Hypertonic saline solution (HSS) can reduce diuretic resistance, increase urinary output and improve renal function in hypervolemic status such as acute heart failure. Therefore, the investigators hypothesized that the use of HSS could prevent or attenuate AKI after heart transplantation in the early postoperative phase. The investigators aim to randomize 74 patients to receive 150 mL of HSS 3,5% or placebo (saline solution 0,9%) twice daily for 3 days after HT. Renal function, right ventricular echocardiographic parameters and pulmonary artery catheter parameters will be assessed. Patients will be followed-up until 30 days, or death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients submitted to orthotopic heart transplantation (HT)\n\nExclusion Criteria:\n\n* Requirement of renal replacement therapy at the time of HT\n* Requirement of extracorporeal membrane oxygenation (ECMO) before or immediately after HT\n* Severe peri-operative mechanical complications\n* Double transplant (e.g. heart-kidney or heart-lung)\n* Hypernatremia (Na ≥ 145)\n* Severe hyponatremia (Na ≤ 120)'}, 'identificationModule': {'nctId': 'NCT05909150', 'acronym': 'HSS-HT', 'briefTitle': 'Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation', 'orgStudyIdInfo': {'id': 'HSS-HT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypertonic Saline Solution 3,5% (HSS)', 'interventionNames': ['Drug: Sodium chloride solution 3,5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline Solution (NS)', 'interventionNames': ['Drug: Sodium chloride solution 0,9%']}], 'interventions': [{'name': 'Sodium chloride solution 3,5%', 'type': 'DRUG', 'description': 'Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.', 'armGroupLabels': ['Hypertonic Saline Solution 3,5% (HSS)']}, {'name': 'Sodium chloride solution 0,9%', 'type': 'DRUG', 'description': 'Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.', 'armGroupLabels': ['Normal Saline Solution (NS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ciro M Murad, MD', 'role': 'CONTACT', 'email': 'ciromurad@hotmail.com'}], 'facility': 'Heart Institute, University of São Paulo.', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Ciro M Murad, MD', 'role': 'CONTACT', 'email': 'ciromurad@hotmail.com', 'phone': '+55 31988988843'}, {'name': 'Núcleo Transplante Heart Institute / University of Sao Paulo', 'role': 'CONTACT', 'phone': '+55 1126615720'}], 'overallOfficials': [{'name': 'Fernando Bacal, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fernando Bacal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Heart Transplant Unit (Heart Institute).', 'investigatorFullName': 'Fernando Bacal', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}