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

NCT06531642 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HSC-MS-24-0411175191
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Urinary Kidney Biomarker Levels

  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)

  From enrollment until 48 hours after injury

Secondary Outcomes (2)

• Acute Kidney Injury Staging

  From enrollment until 5 days of initial injury

• Major Adverse Kidney Events

  From enrollment until 30 days of initial injury

Study Arms (2)

Early Initiation

EXPERIMENTAL

Within 2 hours of emergency department (ED) admission after inclusion criteria is met, administer 1st dose of Protonix (pantoprazole) 40 mg, then followed by 40 mg q12hrs for 2 additional days

Drug: Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days

Usual Care

ACTIVE COMPARATOR

Administer 1st dose of 40 mg Protonix (pantoprazole) at the usual timing (current practice: in the intensive care unit), then followed by 40 mg daily for 2 additional days.

Drug: Protonix (pantoprazole) 40 mg q 24 hrs for 2 days

Interventions

Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days DRUG

Within 2 hours of ED admission after inclusion criteria is met, administer 1st dose of Protonix (pantoprazole) 40mg, then followed by 40mg q12hrs for 2 additional days.

Early Initiation

Protonix (pantoprazole) 40 mg q 24 hrs for 2 days DRUG

Administer 1st dose of 40mg Protonix (pantoprazole) at the usual timing (current practice: in the intensive care unit), then followed by 40mg daily for 2 additional days.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Hemorrhagic

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yafen Liang, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Partial blinded, only the laboratory testing technician/outcome assessor will be blinded to the study arms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor, Chief of Division of Cardiovascular Anesthesiology, Vice Chair of Clinical Research

Model Details: Study group patients will receive pantoprazole early (40 mg iv q12H, within 2 hours of ED arrival and after study enrollment) and control group patients will receive the usual timing (40 mg iv daily, at routine timing, usually in the intensive care unit), then for 2 additional days after the initial injury insult.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 1, 2024
• Study Start: September 7, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)