RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-07
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06531642

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patient (≥18 years of age)
  2. * Patient meets hemorrhagic shock criteria:
  3. * Hypovolemic shock from traumatic acute bleeding
  4. * Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR
  5. * Systolic blood pressure ≤ 70 mmHg at presentation to the ED.
  1. * Patients \<18 years of age
  2. * Patients known to be actively on renal replacement therapy
  3. * Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours
  4. * History of PPI sensitivity or allergy
  5. * Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment
  6. * Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis
  7. * Vulnerable populations such as pregnant women and prisoners

Contacts and Locations

Study Contact

Yafen Liang, MD
CONTACT
713-500-6226
yafen.liang@uth.tmc.edu
Simon Betancourt Escobar, MD
CONTACT
346-383-2859
simon.betancourtescobar.1@uth.tmc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-07
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2024-09-07
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Acute Kidney Injury
  • AKI
  • Proton Pump Inhibitors
  • Hemorrhagic Shock
  • Trauma Patients
  • PPI
  • Randomized Controlled Trial

Additional Relevant MeSH Terms

  • Acute Kidney Injury