Clinical trial NCT06531642: Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
Official title: Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury (CEPU-AKI) in Hemorrhagic Shock Patients: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
AKI
Proton Pump Inhibitors
Hemorrhagic Shock
Trauma Patients
PPI
Randomized Controlled Trial
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2024-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Urinary Kidney Biomarker Levels
timeFrame: From enrollment until 48 hours after injury
Secondary outcomes:
measure: Acute Kidney Injury Staging
timeFrame: From enrollment until 5 days of initial injury
measure: Major Adverse Kidney Events
timeFrame: From enrollment until 30 days of initial injury
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Yafen Liang, MD
role: PRINCIPAL_INVESTIGATOR
References: