Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-04 @ 10:37 PM
Study NCT ID:
NCT06547892
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014667', 'term': 'Vasopressins'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization list will be generated with appropriate software, in blocks of 4, by a statistician not involved in patient care. There will be stratification by center. Randomization confidentiality will be guaranteed by central randomization via REDCap.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical, multicenter, placebo-controlled, double-blind, randomized and feasibility trial with a proposal to include 60 patients in 3 to 4 research centers.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Mortality will be defined by medical records'}], 'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '6 months', 'description': 'Defined by the inclusion of 60 patients in 3 or more ICUs over a period of 6 months'}], 'secondaryOutcomes': [{'measure': 'Creatinine, in mg/dL', 'timeFrame': '7 days', 'description': 'Creatinine will be defined by laboratory analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.', 'detailedDescription': 'This is a multicenter, placebo-controlled, double-blind, randomized feasibility clinical trial with a proposal to include 60 patients across 3 to 4 research centers.\n\nThis study will be conducted in Brazilian hospitals, covering both public and private healthcare profiles across various states of Brazil. Most of these hospitals are academic and teaching institutions, ensuring a wide diversity of data and perspectives for the research.\n\nThe objective of this study is to assess the feasibility of conducting a larger subsequent trial to analyze whether the use of vasopressin in patients prone to developing acute kidney dysfunction after admission to intensive care units (ICUs) can prevent the condition (acute kidney dysfunction).\n\nThis study is based on the null hypothesis (H0) that there will be no significant difference in the development of acute kidney injury between the group treated with vasopressin and the control group, while the alternative hypothesis (H1) proposes that the administration of vasopressin may reduce the risk of acute kidney injury in high-risk patients admitted to ICUs. The primary objective is to evaluate the feasibility of the study, specifically adherence to the established protocol and the monitoring of potential adverse effects during its conduct.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years old);\n* Admitted to intensive care units;\n* Predicted risk of acute kidney injury calculated based on clinical and laboratory data at ICU admission and is considered eligible if the value in the calculator is equal or greater than 5 points;\n\nExclusion Criteria:\n\n* Time since admission to the ICU greater than 24 hours;\n* Use of vasopressors at the time of inclusion;\n* MAP \\>90 mmHg;\n* Hyponatremia (\\<130 mmol/L);\n* Severe TBI with Glasgow Coma Scale \\< 8;\n* Elective surgeries;\n* Dialysis chronic kidney disease or acute kidney injury who received renal replacement therapy upon admission or are expected to receive renal replacement therapy within the next 24 hours;\n* Suspected or confirmed acute mesenteric ischemia;\n* Prospect of death in less than 24 hours;\n* Medical team not committed to full investment at the time of inclusion;\n* Prior inclusion in the study;\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06547892', 'acronym': 'NOVA-AKI', 'briefTitle': 'Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU: a Feasibility Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'NOVA-AKI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vasopressin', 'description': 'To dilute vasopressin, an ampoule containing 20 IU/ml (1 ml) of vasopressin will be used, which will be mixed with 100 ml of 0.9% physiological solution, resulting in a solution with a concentration of 0.2 IU/ ml. In this study, both central and peripheral vein infusion will be permitted.\n\nThe vasopressin administration protocol will consist of an initial dose of 0.02 IU/min (equivalent to 6 ml/h), which can be increased to 0.03 IU/min (9 ml/h) if the mean arterial pressure (MAP) is less than or equal to 65 mmHg. On the other hand, if MAP exceeds 90 mmHg, the dose can be reduced to 0.01 IU/min (3 ml/h). The minimum period for adjusting the drug dosage should be one hour.\n\nIn the event that a MAP exceeds 100 mmHg persists, the dose of the drug can be reduced more quickly or even stopped. The duration of vasopressin therapy will be maintained for 7 days, discharge from the ICU, initiation of renal replacement therapy or until death, whichever occurs first.', 'interventionNames': ['Drug: Vasopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.', 'interventionNames': ['Other: 0,9% saline solution']}], 'interventions': [{'name': 'Vasopressin', 'type': 'DRUG', 'description': 'To dilute vasopressin, an ampoule containing 20 IU/ml (1 ml) of vasopressin will be used, which will be mixed with 100 ml of 0.9% physiological solution, resulting in a solution with a concentration of 0.2 IU/ ml. In this study, both central and peripheral vein infusion will be permitted.\n\nThe vasopressin administration protocol will consist of an initial dose of 0.02 IU/min (equivalent to 6 ml/h), which can be increased to 0.03 IU/min (9 ml/h) if the mean arterial pressure (MAP) is less than or equal to 65 mmHg. On the other hand, if MAP exceeds 90 mmHg, the dose can be reduced to 0.01 IU/min (3 ml/h). The minimum period for adjusting the drug dosage should be one hour.', 'armGroupLabels': ['Vasopressin']}, {'name': '0,9% saline solution', 'type': 'OTHER', 'description': 'Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03115-001', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Matheus Liguori Feliciano da Silva D Silva, MD', 'role': 'CONTACT', 'email': 'matheus_liguori@hotmail.com', 'phone': '1198282-3920'}], 'facility': 'Matheus Liguori Feliciano da Silva', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Matheus Silva', 'role': 'CONTACT', 'email': 'matheus_liguori@hotmail.com', 'phone': '+55 11 98282-3920'}], 'overallOfficials': [{'name': 'Matheus Silva', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coracao'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '20 months', 'ipdSharing': 'YES', 'description': 'Our data dissemination plan will follow the rules of the research institute (Hcor)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}