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RECRUITING
NCT06531642
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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