← Back to Search

Proton Pump Inhibitor

Pantoprazole for Acute Kidney Injury in Hemorrhagic Shock (Trauma AKI PPI Trial)

Phase 2 & 3

Recruiting

Led By Yafen Liang, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patient (≥18 years of age)

Patient meets hemorrhagic shock criteria: Hypovolemic shock from traumatic acute bleeding with 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.

Must not have

Cardiac arrest prior to ED arrival or expected survival of less than 24 hours

Patients known to be actively on renal replacement therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment until 48 hours after injury

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if giving a drug called pantoprazole early can help reduce kidney damage in trauma patients with severe bleeding. They will compare patients who receive the drug early to those who receive

Who is the study for?

This trial is for trauma patients who have experienced hemorrhagic shock and are at risk of acute kidney injury. Participants must be within a specific cohort of 100 patients to receive either early or routine pantoprazole treatment after their initial injury.

What is being tested?

The study tests if giving the proton pump inhibitor pantoprazole early can reduce kidney damage in trauma patients with hemorrhagic shock, compared to standard timing. It measures kidney health by checking biomarkers and tracking adverse events up to day 30.

What are the potential side effects?

Pantoprazole may cause side effects like headaches, diarrhea, nausea, stomach pain, vomiting, gas, dizziness, and joint pain. Serious but rare side effects include severe allergic reactions and vitamin B12 deficiency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I was in shock due to severe bleeding with very low blood pressure and a fast heart rate when I arrived at the emergency department.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had a cardiac arrest before getting to the ER or am expected to live less than 24 hours.

Select...

I am currently on dialysis.

Select...

I need a higher dose of medicine because of ongoing stomach bleeding.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment until 48 hours after injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment until 48 hours after injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until 48 hours after injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary Kidney Biomarker Levels

Secondary study objectives

Acute Kidney Injury Staging

Major Adverse Kidney Events

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01801280

21%

Common cold

Noro virus infection

100%

80%

60%

40%

20%

Study treatment Arm

Mycophenolate Mofetil (MMF)

MMF + PAN

EC-MPS

EC-MPS + PAN

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early InitiationExperimental Treatment1 Intervention

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 II: Usual CareActive Control1 Intervention

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.

0 / 6Eligibility criteria met