RecruitingPhase 2/3

Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients

United States100 participantsStarted 2024-09-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Urinary Kidney Biomarker Levels

Timeframe: From enrollment until 48 hours after injury

Trial details

NCT IDNCT06531642

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Yafen Liang, MD

713-500-6226 yafen.liang@uth.tmc.edu