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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllThe University of Texas Health Science Center, Ho…
NCT06531642 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days
  • Protonix (pantoprazole) 40 mg q 24 hrs for 2 days
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Where

1 site
Memorial Hermann Texas Medical Center
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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