Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT06706258
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute Kidney Injury (AKI)', 'timeFrame': 'From enrollment to 7 days or until hospital discharge, if earlier.', 'description': 'The investigators will calculate the incidence of acute kidney injury (AKI) within 7 days (or until hospital discharge if earlier) of cardiac surgery in patients receiving pantoprazole vs. famotidine.'}], 'secondaryOutcomes': [{'measure': 'Urinary Kidney Injury Biomarkers Levels', 'timeFrame': 'From enrollment to 72 hours after ICU admission', 'description': 'The investigators will measure the urinary kidney biomarker KIM-1 (kidney injury molecule-1) and neutrophil gelatinase-associated lipocalin (NGAL) levels at the different time points of urine sample collection (baseline, chest closure, and 8, 24, 48 and 72 hrs after ICU admission)'}, {'measure': 'Major Adverse Kidney Events (MAKE)', 'timeFrame': 'From enrollment to 30 days after cardiac surgery', 'description': 'The investigators will follow up on patients enrolled in the study and ask about patient demise, necessity of dialysis of any type, hospitalizations due to renal problems, or sustained kidney dysfunction after 30 days of enrollment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'AKI', 'Cardiac Surgery', 'Cardiovascular Surgery', 'PPI', 'Proton Pump Inhibitors', 'Perioperative Medicine', 'Anesthesiology', 'Intensive Care Unit', 'ICU', 'Kidney'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The central hypothesis of this research study is that perioperative administration of the proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney injury (AKI) following cardiac surgery by activation molecular pathways for kidney protection. The investigators propose a single-center, randomized, controlled, single-blinded trial to determine whether perioperative intravenous administration of pantoprazole will reduce the incidence of AKI, some molecules that can be detected the urine, and major adverse kidney events (MAKE) at day 30 postoperatively, compared to famotidine after cardiac surgery. The specific aims of the study will be achieved by randomizing a group of 400 patients to receive pantoprazole (study) or famotidine (control) for 3 days perioperatively.\n\nOur study population will include any adult patients (aged over 18 years) scheduled for cardiac surgery requiring a cardiopulmonary bypass machine.', 'detailedDescription': 'Each year more than 500,000 cardiac surgeries are performed in the USA alone. AKI is a common complication following cardiac surgery and is associated with poor patient outcome and increased health care cost. Therefore, there is an urgent need to identify medical interventions and treatments that prevent AKI or mitigate its severity when it occurs after cardiac surgery.\n\nOne of the main causes of AKI following cardiac surgery involves renal hypoperfusion/ischemia and reperfusion injury. Hypoxia inducible factors (HIFs) are key transcription factors responsible for tissue adaptation to low oxygen, which orchestrate the expression of a wide variety of genes including a set of microRNAs. MicroRNAs are endogenous single-stranded noncoding miRNAs of nucleotides that participate in physiological and pathological functions via regulating post-transcription of target genes. During ischemic injury, hypoxia upregulates endothelial MicroRNAs that have a potential in renal protection through vascular integrity and regeneration. Additionally, microRNAs exert protective effects via decreasing apoptosis and promoting tubular cell proliferation during ischemic AKI. Moreover, decreased serum levels of MicroRNAs are highly correlated with AKI severity in the intensive care unit (ICU) patients.\n\nOur preliminary study identified ATP4A as the downstream target gene of MicroRNAs in the kidney. ATP4A (catalytic α subunit of H+/K+ ATPase) is located in intercalated cells in the distal tubules and cortical collecting ducts, which regulates urine acidification through secretion of hydrogen and reabsorption of potassium from urine. Proton pump inhibitors (PPIs) block the ATP hydrolysis of the H+/K+ ATPase via binding its active site of ATP4A and further enhance this endogenous kidney protection pathway. Despite robust animal model data, randomized controlled trial aiming to test the effectiveness of PPI in post-cardiac surgery AKI prevention is lacking. If proven to be effective, our studies could be easily implemented in clinical practice and serve as an effective treatment for perioperative AKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age 18-90).\n* Scheduled for elective cardiac surgery with cardiopulmonary bypass.\n* Moderate to high risk of developing AKI (Cleveland risk score equal to or higher than 3.\n\nExclusion Criteria:\n\n* Patients with preoperative eGFR\\<30 ml/min/1.73 m2\n* Dialysis dependence\n* Emergency surgery\n* Pregnancy.\n* Nursing patient\n* Patients with interstitial nephritis\n* PPIs hypersensitivity\n* Liver disease\n* Vitamin B12 deficiency.'}, 'identificationModule': {'nctId': 'NCT06706258', 'acronym': 'P2 AKI PPI', 'briefTitle': 'Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial): A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-24-1034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pantoprazole Group', 'description': 'Pantoprazole (Protonix) will be given at 6 different timepoints:\n\n1. After anesthesia induction, before surgical incision.\n2. At chest closure. 3 \\& 4. Every 12 hrs in post operative day 1. 5 \\& 6. Every 12 hrs in post operative day 2.', 'interventionNames': ['Drug: Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Famotidine Group', 'description': 'Famotidine (Pepcid) will be given at 6 different timepoints:\n\n1. After anesthesia induction, before surgical incision.\n2. At chest closure. 3 \\& 4. Every 12 hrs in post operative day 1. 5 \\& 6. Every 12 hrs in post operative day 2.', 'interventionNames': ['Drug: Pepcid (Famotidine) 20 mg q 12 hrs for 3 days']}], 'interventions': [{'name': 'Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days', 'type': 'DRUG', 'description': 'Administer 1st dose after anesthesia induction before surgical incision, 2nd dose at chest closure. Then, every 12 hrs for 2 more days.', 'armGroupLabels': ['Pantoprazole Group']}, {'name': 'Pepcid (Famotidine) 20 mg q 12 hrs for 3 days', 'type': 'DRUG', 'description': 'Administer 1st dose after anesthesia induction before surgical incision, 2nd dose at chest closure. Then, every 12 hrs for 2 more days.', 'armGroupLabels': ['Famotidine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yafen Liang, MD', 'role': 'CONTACT', 'email': 'yafen.liang@uth.tmc.edu', 'phone': '713-500-6226'}, {'name': 'Simon Betancourt Escobar, MD', 'role': 'CONTACT', 'email': 'simon.betancourtescobar.1@uth.tmc.edu', 'phone': '713-500-5739'}, {'name': 'Yafen Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Hermann Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Yafen Liang, MD', 'role': 'CONTACT', 'email': 'yafen.liang@uth.tmc.edu', 'phone': '713-500-6226'}, {'name': 'Simon Betancourt Escobar, MD', 'role': 'CONTACT', 'email': 'simon.betancourtescobar.1@uth.tmc.edu', 'phone': '713-500-5739'}], 'overallOfficials': [{'name': 'Yafen Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'url': 'https://register.clinicaltrials.gov/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'IPD will be available and uploaded on clinicaltrials.gov website when it is due.', 'ipdSharing': 'YES', 'description': 'The IPD will be shared upon request by the journal.', 'accessCriteria': 'Accesible through the clinicaltrials.gov website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.; Professor; Chief, Division of Cardiovascular Anesthesiology; Vice Chair, Clinical Research', 'investigatorFullName': 'yafen liang', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}