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Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
Sponsor: The University of Texas Health Science Center, Houston
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-09-07
Completion Date
2026-09-01
Last Updated
2026-02-19
Healthy Volunteers
Yes
Conditions
Interventions
Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days
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.
Protonix (pantoprazole) 40 mg q 24 hrs for 2 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)
Memorial Hermann Texas Medical Center
Houston, Texas, United States