Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury (CEPU-AKI) in Hemorrhagic Shock Patients: A Prospective Randomized Controlled Trial
The University of Texas Health Science Center, Houston
100 participants
Sep 7, 2024
INTERVENTIONAL
Conditions
Summary
The investigators propose a single-center, randomized, controlled trial to determine whether early initiation of proton pump inhibitor (PPI), pantoprazole, will decrease acute kidney injury (AKI) for trauma patients presenting with hemorrhagic shock compared to routine timing of initiation of PPI. Kidney injury will be assessed by the urinary kidney injury biomarkers, and the incidence, severity and AKI-free days within first week and major adverse kidney events (MAKE) at day 30. The specific aims of the study will be achieved by a cohort of 100 patients to receive either early(study) or routine (control) administration of pantoprazole for 2 days after the initial injury insult.
Eligibility
Inclusion Criteria5
- Adult patient (≥18 years of age)
- Patient meets hemorrhagic shock criteria:
- Hypovolemic shock from traumatic acute bleeding
- Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR
- Systolic blood pressure ≤ 70 mmHg at presentation to the ED.
Exclusion Criteria7
- Patients <18 years of age
- Patients known to be actively on renal replacement therapy
- Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours
- History of PPI sensitivity or allergy
- Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment
- Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis
- Vulnerable populations such as pregnant women and prisoners
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Interventions
Within 2 hours of ED admission after inclusion criteria is met, administer 1st dose of Protonix (pantoprazole) 40mg, then followed by 40mg q12hrs for 2 additional days.
Administer 1st dose of 40mg Protonix (pantoprazole) at the usual timing (current practice: in the intensive care unit), then followed by 40mg daily for 2 additional days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06531642