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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Houston

Memorial Hermann Texas Medical Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Yafen Liang, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2025-07-31