Recruiting
Phase 2
Phase 3

Proton Pump Inhibitor vs. Usual Care

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06531642

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days

Protonix (pantoprazole) 40 mg q 24 hrs for 2 days

Study Details

Brief 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.

Conditions

Acute Kidney Injury

Study ID

NCT06531642

Start date

Sep 7, 2024

Status verified date

Feb, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Early Initiation

Within 2 hours of emergency department (ED) admission after inclusion criteria is met, administer 1st dose of Protonix (pantoprazole) 40 mg, then followed by 40 mg q12hrs for 2 additional days

active comparator: Usual Care

Administer 1st dose of 40 mg Protonix (pantoprazole) at the usual timing (current practice: in the intensive care unit), then followed by 40 mg daily for 2 additional days.

Interventions

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.

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.

Primary outcome measure

  • Urinary Kidney Biomarker Levels [ Time Frame: From enrollment until 48 hours after injury ]

Central Contacts and Locations

Central contacts

Yafen Liang, MD

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

Simon Betancourt Escobar, MD

346-383-2859simon.betancourtescobar.1@uth.tmc.edu

Locations

Memorial Hermann Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Yafen Liang, MD

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

Simon Betancourt Escobar, MD

3463832859simon.betancourtescobar.1@uth.tmc.edu

Principal Investigator:

Yafen Liang, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Acute Kidney Injury
  • AKI
  • Proton Pump Inhibitors
  • Hemorrhagic Shock
  • Trauma Patients
  • PPI
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-02-19.