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NCT06531642 · ClinicalTrials.gov registry record · Phase 2
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
A Phase 2 study of Acute Kidney Injury, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06531642: Recruiting Phase 2 study of Acute Kidney Injury, sponsored by The University of Texas Health Science Center, Houston.
NCT06531642 is a Phase 2 study of Acute Kidney Injury that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 100 participants, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06531642, a Phase 2 study of Acute Kidney Injury, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The investigators will measure the urinary kidney biomarker KIM-1 (kidney injury molecule-1) levels at the different time points of urine sample collection (baseline, 8 hrs, 24 hrs and 48 hrs)
Conditions Studied
Interventions
- DRUG Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days
- DRUG Protonix (pantoprazole) 40 mg q 24 hrs for 2 days
Study Locations (1)
Texas
- Memorial Hermann Texas Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-09-07 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 2 |
What NCT06531642 shows while recruiting
NCT06531642 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions - of which Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days is the first listed.
NCT06531642 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06531642 about?
NCT06531642 is a clinical study titled "Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients". 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. K...
What is the current status of trial NCT06531642?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-09-07. Estimated completion is 2026-09-01.
What conditions does trial NCT06531642 study?
This clinical trial studies the following conditions: Acute Kidney Injury.
What interventions are being tested in trial NCT06531642?
The interventions under investigation include: Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days (DRUG), Protonix (pantoprazole) 40 mg q 24 hrs for 2 days (DRUG).
Who is sponsoring clinical trial NCT06531642?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06531642 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Kidney Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06531642's enrollment target sits among peer trials
100 44th of 74 higher than 28 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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