Acute Kidney InjuryPhase 2/3Trauma AKI PPINCT06531642
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
A Phase 2/3 study testing Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days and Protonix (pantoprazole) 40 mg q 24 hrs for 2 days in people with Acute Kidney Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days and Protonix (pantoprazole) 40 mg q 24 hrs for 2 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2024to 1 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
Yafen Liang, MD, 713-500-6226, yafen.liang@uth.tmc.edu
Simon Betancourt Escobar, MD, 3463832859, simon.betancourtescobar.1@uth.tmc.edu
About this study
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
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.
Read the 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
- Being tested
- Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days, Protonix (pantoprazole) 40 mg q 24 hrs for 2 days
- Keywords
- Acute Kidney Injury, AKI, Proton Pump Inhibitors, Hemorrhagic Shock, Trauma Patients, PPI, Randomized Controlled Trial
- Medical subject headings
- Acute Kidney Injury, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protonix (Pantoprazole) 40 mg q 12 hrs for 2 daysDrug
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.
Protonix (pantoprazole) 40 mg q 24 hrs for 2 daysDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Protonix (pantoprazole) 40 mg q 24 hrs for 2 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment until 48 hours after injury
Secondary outcomes (2)
Acute Kidney Injury Staging
The investigators will classify each patient to an AKI stage (1, 2 or 3) according to the 2012 Kidney Disease Improving Global Outcomes (KDIGO) which uses creatinine levels and estimated glomerular filtration rate (eGFR) levels each day for 5 days after enrollment.
Measured: From enrollment until 5 days of initial injury
Major Adverse Kidney Events
The investigators will follow up on patients enrolled in the study and ask about patient demise, necessity of dialysis of any type, hospitalizations due to renal problems, or sustained kidney dysfunction after 30 days of enrollment.
Measured: From enrollment until 30 days of initial injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start7 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yafen liang, The University of Texas Health Science Center, Houston
- Investigators
- Yafen Liang, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531642
- Sponsor's protocol ID
- HSC-MS-24-0411
- Other IDs
- 175191
- Acronym
- Trauma AKI PPI
- Status last verified
- Feb 2026
- First submitted
- 19 Jul 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06531642
- Acronym / sponsor ID
- Trauma AKI PPI / HSC-MS-24-0411
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, AKI, Proton Pump Inhibitors, Hemorrhagic Shock, Trauma Patients, PPI, Randomized Controlled Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Initiation | Experimental | Drug: Protonix (Pantoprazole) 40 mg q 12 hrs for 2 daysWithin 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 |
| Usual Care | Active comparator | Drug: Protonix (pantoprazole) 40 mg q 24 hrs for 2 daysAdminister 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protonix (Pantoprazole) 40 mg q 12 hrs for 2 daysWithin 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. | Drug | Early Initiation |
| Protonix (pantoprazole) 40 mg q 24 hrs for 2 daysAdminister 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. | Drug | Usual Care |
Primary outcome
Urinary Kidney Biomarker Levels
Time frame: From 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)
2 secondary outcomes
Acute Kidney Injury Staging
Time frame: From enrollment until 5 days of initial injury
Major Adverse Kidney Events
Time frame: From enrollment until 30 days of initial injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yafen Liang, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days and Protonix (pantoprazole) 40 mg q 24 hrs for 2 days in people with Acute Kidney Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yafen Liang, MD (713-500-6226, yafen.liang@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Kidney Biomarker Levels (time frame: From enrollment until 48 hours after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.