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Protonix for Acute Kidney Injury in Hemorrhagic Shock

This study is looking at whether giving a medication called Protonix (pantoprazole) earlier can help prevent acute kidney injury (AKI) in people who have severe bleeding (hemorrhagic shock) due to trauma. AKI is a serious condition where your kidneys suddenly stop working well. Researchers want to see if giving Protonix within 2 hours of arriving at the emergency department, compared to the usual timing, can reduce kidney damage. They will measure kidney injury using urine tests. This study plans to include 100 adults who are at least 18 years old and have hemorrhagic shock from traumatic bleeding.

Study design
This is a randomized, controlled study involving 100 participants. Participants will be randomly assigned to receive Protonix either early or at the usual time.
What's involved
Participants will receive Protonix (pantoprazole) for 2 days. Kidney biomarker levels will be measured from enrollment until 48 hours after injury.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the incidence and severity of AKI, AKI-free days within the first week, and major adverse kidney events (MAKE) at day 30.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06531642

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

Recruiting
PHASE2Ages 18+InterventionalPrevention
The University of Texas Health Science Center, Houston
~100 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Protonix (Pantoprazole) 40 mg q 12 hrs for 2 daysProtonix (pantoprazole) 40 mg q 24 hrs for 2 days

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary Kidney Biomarker Levels
Measured over From enrollment until 48 hours after injury

Conditions

Acute Kidney Injury

Explore related trials

Hemorrhagic ShockInjury

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Yafen Liang, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Yafen Liang, MD
[email protected]
713-500-6226
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Urinary Kidney Biomarker LevelsFrom enrollment until 48 hours after injury

    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)