Status:
RECRUITING
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
The University of Texas Health Science Center at San Antonio
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Traumatic injuries account for 10% of all deaths globally and are the leading cause of mortality for trauma patients under 46 in the United States. Hemorrhage is the primary cause of death in both civ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06531642
Start Date
September 7 2024
End Date
July 31 2025
Last Update
September 27 2024
Active Locations (1)
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1
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030