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Proton Pump Inhibitor

Early Initiation for Acute Kidney Injury (Trauma AKI PPI Trial)

Phase 2 & 3
Waitlist Available
Led By Yafen Liang, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Adult patient (≥18 years of age)
* Hypovolemic shock from traumatic acute bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until 48 hours after injury
Awards & highlights

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 is the study for?
This trial is for trauma patients who have experienced hemorrhagic shock and are at risk of acute kidney injury. Participants must be within a specific cohort of 100 patients to receive either early or routine pantoprazole treatment after their initial injury.
What is being tested?
The study tests if giving the proton pump inhibitor pantoprazole early can reduce kidney damage in trauma patients with hemorrhagic shock, compared to standard timing. It measures kidney health by checking biomarkers and tracking adverse events up to day 30.
What are the potential side effects?
Pantoprazole may cause side effects like headaches, diarrhea, nausea, stomach pain, vomiting, gas, dizziness, and joint pain. Serious but rare side effects include severe allergic reactions and vitamin B12 deficiency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until 48 hours after injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until 48 hours after injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary Kidney Biomarker Levels
Secondary outcome measures
Acute Kidney Injury Staging
Major Adverse Kidney Events

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01801280
21%
Common cold
5%
Noro virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil (MMF)
MMF + PAN
EC-MPS
EC-MPS + PAN

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early InitiationExperimental Treatment1 Intervention
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
Group II: Usual CareActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
926 Previous Clinical Trials
333,421 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
515 Patients Enrolled for Acute Kidney Injury
The University of Texas Health Science Center at San AntonioOTHER
463 Previous Clinical Trials
91,899 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
1,118 Patients Enrolled for Acute Kidney Injury
Yafen Liang, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
100 Patients Enrolled for Acute Kidney Injury
~67 spots leftby Jul 2025
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