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

NCT ID: NCT06531642

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-07
• Study Completion Date: 2025-07-31

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.

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 civilian and military trauma scenarios worldwide. Following hemorrhage and traumatic brain injury, organ failure, including acute kidney injury (AKI), is the third leading cause of death in trauma patients. AKI occurs in up to 50% of patients with hemorrhagic shock and is linked to increased morbidity, extended hospital stays, progression to chronic kidney disease, and higher short- and long-term mortality rates. Even patients with mild AKI, as classified by the RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease), face a 2.5 times higher risk of mortality. Battlefield conditions often delay access to definitive medical care for injured soldiers, highlighting the urgent need for effective shock treatments to minimize organ damage, such as AKI.

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.

Our study will include adults (over 18 years old) who meet the criteria for hemorrhagic shock, as these patients are more susceptible to hypoxic kidney damage due to bleeding and hypovolemia. This will allow us to assess whether early PPI initiation can better protect the kidneys during the early stages of hypoxic damage.

To evaluate this, the investigators will measure urinary kidney injury biomarkers in trauma patients to compare early pantoprazole initiation (study group) with the usual timing of PPI initiation (control group) (n=100, primary endpoint). Additionally, the investigators will assess whether early pantoprazole initiation decreases the incidence, severity, and number of AKI-free days within the first week post-hemorrhagic shock, as well as major adverse kidney events (MAKE: a composite of death, dialysis, renal hospitalization, or sustained kidney dysfunction) 30 days after the initial injury.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early Initiation

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

yafen liang

M.D., Professor, Chief of Division of Cardiovascular Anesthesiology, Vice Chair of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yafen Liang, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yafen Liang, MD

Role: CONTACT

yafen.liang@uth.tmc.edu

713-500-6226

Simon Betancourt Escobar, MD

Role: CONTACT

simon.betancourtescobar.1@uth.tmc.edu

346-383-2859

Facility Contacts

Yafen Liang, MD

Role: primary

yafen.liang@uth.tmc.edu

713-500-6226

Simon Betancourt Escobar, MD

Role: backup

simon.betancourtescobar.1@uth.tmc.edu

3463832859

Yafen Liang, MD

Role: backup

Other Identifiers

175191

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC-MS-24-0411

Identifier Type: -

Identifier Source: org_study_id