Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT06531642

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

Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-19

100

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center, Houston

Lead Sponsor

T

The University of Texas Health Science Center at San Antonio

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient 18 years of age or older
  • Patient meets hemorrhagic shock criteria with hypovolemic shock from traumatic acute bleeding
  • Systolic blood pressure 90 mmHg or less AND heart rate 108 or higher at emergency department presentation; OR
  • Systolic blood pressure 70 mmHg or less at emergency department presentation
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Patients currently on renal replacement therapy
  • Cardiac arrest before emergency department arrival or expected survival less than 24 hours
  • History of sensitivity or allergy to proton pump inhibitors
  • Patients enrolled in other trials that do not allow co-enrollment
  • Patients with ongoing gastrointestinal bleeding requiring higher dose gastrointestinal prophylaxis
  • Vulnerable populations such as pregnant women and prisoners

AI-Screening

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Trial Site Locations

Total: 1 location

1

Memorial Hermann Texas Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

Y

Yafen Liang, MD

CONTACT

S

Simon Betancourt Escobar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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