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RecruitingAccepts healthy volunteersPhase 2/Phase 3

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

The University of Texas Health Science Center, Houston · with The University of Texas Health Science Center at San Antonio · NCT06531642

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
100
US sites recruiting
1
Study start
September 7, 2024
Record last updated
February 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days; Protonix (pantoprazole) 40 mg q 24 hrs for 2 days

Conditions: Acute Kidney Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Memorial Hermann Texas Medical Center

    Houston, TX 77030

    Site contact: Yafen Liang, MD · 713-500-6226 · yafen.liang@uth.tmc.edu

Study contacts (from the official record)

  • Yafen Liang, MD · 713-500-6226 · yafen.liang@uth.tmc.edu
  • Simon Betancourt Escobar, MD · 346-383-2859 · simon.betancourtescobar.1@uth.tmc.edu
All healthy volunteers studies in Texas →
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual… (NCT06531642) | Bored Studies