NCT06531642 Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
| NCT ID | NCT06531642 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-07 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-09-07 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Yafen Liang, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06531642 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06531642 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06531642 currently recruiting?
Yes, NCT06531642 is actively recruiting participants. Contact the research team at yafen.liang@uth.tmc.edu for enrollment information.
Where is the NCT06531642 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06531642 clinical trial?
NCT06531642 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Yafen Liang, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 100 participants.
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