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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06531642
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 7, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Hermann Texas Medical CenterHoustonTexas77030
Yafen Liang, MD
[email protected]
713-500-6226
Simon Betancourt Escobar, MD
[email protected]
3463832859
Yafen Liang, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Memorial Hermann Texas Medical Center· Houston, TX

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