Home › Acute Kidney Injury › NCT06531642

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

Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury (CEPU-AKI) in Hemorrhagic Shock Patients: A Prospective Randomized Controlled Trial

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days (drug)
• Protonix (pantoprazole) 40 mg q 24 hrs for 2 days (drug)

Sponsor: The University of Texas Health Science Center, Houston · Participants: 100 · Started: Sep 7, 2024

Contact the study team

• Yafen Liang, MD · Phone: 713-500-6226
• Simon Betancourt Escobar, MD · Phone: 346-383-2859

Official record on ClinicalTrials.gov — NCT06531642

Locations in the U.S.

Conditions

• Acute Kidney Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.