RecruitingPhase 2Phase 3NCT06531642

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

100 participants

Start Date

Sep 7, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days and a drug called Protonix (pantoprazole) 40 mg q 24 hrs for 2 days for people with acute kidney injury. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProtonix (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.

DRUGProtonix (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

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NCT06531642


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