Pantoprazole for Acute Kidney Injury in Hemorrhagic Shock

(Trauma AKI PPI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Yafen Liang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Proton pump inhibitors

Disqualifiers: Renal replacement therapy, Cardiac arrest, others

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the drug pantoprazole effective in preventing kidney injury?

Research suggests that pantoprazole may help protect against kidney injury caused by cisplatin, a chemotherapy drug, as it prevented increases in kidney injury markers in patients receiving cisplatin treatment. ^{1 2 3 4 5}

Is pantoprazole generally safe for humans?

Pantoprazole is generally considered safe and has been used for over 13 years in more than 100 countries with an excellent safety profile. However, rare side effects have been reported, including liver toxicity, a significant drop in platelet count (thrombocytopenia), and drug-induced fever. These side effects are uncommon, but they should be considered when using pantoprazole. ^{2 6 7 8 9}

How does the drug pantoprazole differ from other treatments for acute kidney injury in hemorrhagic shock?

Pantoprazole is unique because it is a proton pump inhibitor (PPI) that can be administered intravenously, making it suitable for acutely ill patients who cannot take oral medications. It also has anti-inflammatory effects, which may help reduce kidney damage in conditions like renal ischemia/reperfusion injury, potentially offering benefits beyond its primary use for acid-related disorders. ^{10 11 12 13 14}

Research Team

Yafen Liang, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

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

I am currently on dialysis.

History of PPI sensitivity or allergy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either early or routine administration of pantoprazole for 2 days after the initial injury

2 days

Daily monitoring in the intensive care unit

Initial Follow-up

Participants are monitored for urinary kidney biomarker levels and AKI staging for 5 days after enrollment

5 days

Daily assessments

Extended Follow-up

Participants are monitored for major adverse kidney events (MAKE) 30 days after the initial injury

30 days

Treatment Details

Interventions

• Pantoprazole (Proton Pump Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Early Initiation Experimental Treatment 1 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 Care Active Control 1 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.

Pantoprazole is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in Japan as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in China as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in Switzerland as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Hermann Texas Medical Center Houston, TX

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Patients Recruited

361,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Patients Recruited

92,500+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent intravenous pantoprazole and continuous cimetidine infusion: effect on gastric pH control in critically ill patients at risk of developing stress-related mucosal disease. Somberg, L., Morris, J., Fantus, R., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole-induced Thrombocytopenia: Unresponsive to Corticosteroid and Thrombocyte Concentrate Transfusion. Widyati, ., Latifah, N., Ramadhani, M.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial. Marker, S., Perner, A., Wetterslev, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible protective effect of pantoprazole against cisplatin-induced nephrotoxicity in head and neck cancer patients: a randomized controlled trial. Ghonaim, E., El-Haggar, S., Gohar, S.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic optimisation of the treatment of peptic ulcer in patients with renal failure. Gladziwa, U., Koltz, U.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver hepatotoxicity associated with pantoprazole: a rare case report. Aslan, M., Celik, Y., Karadas, S., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug fever due to a single dose of pantoprazole. Schiller, D., Maieron, A., Schöfl, R., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole: a proton pump inhibitor with oral and intravenous formulations. Devault, KR.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation lethality potentiation in total body irradiated mice by a commonly prescribed proton pump inhibitor, Pantoprazole sodium. Biju, PG., Gubrij, I., Garg, S., et al.[2021]

Pantoprazole is an effective proton pump inhibitor that, when used in combination with antibiotics, achieves Helicobacter pylori eradication rates of 71-93.8% in patients without known antibiotic resistance, making it a strong option for treating this infection.

In treating gastro-oesophageal reflux disease (GORD), pantoprazole is as effective as other PPIs and significantly better than histamine H(2)-antagonists, with good tolerability and minimal drug interactions, providing flexibility with both oral and intravenous formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole: an update of its pharmacological properties and therapeutic use in the management of acid-related disorders. Cheer, SM., Prakash, A., Faulds, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole-induced acute interstitial nephritis. Moore, I., Sayer, JA., Nayar, A., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The protective effect of acute pantoprazole pretreatment on renal ischemia/reperfusion injury in rats. Kohansal, P., Rajai, N., Dehpour, AR., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Superiority of pantoprazole over ranitidine in the treatment of duodenal ulcer. Mexican clinical experience. Mexican Study Group of Pantoprazole++ in Duodenal Ulcer]. Dibildox, M., Rose, K., Tomás-Pons, J., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous pantoprazole: a new tool for acutely ill patients who require acid suppression. Trépanier, EF.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intermittent intravenous pantoprazole and continuous cimetidine infusion: effect on gastric pH control in critically ill patients at risk of developing stress-related mucosal disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pantoprazole-induced Thrombocytopenia: Unresponsive to Corticosteroid and Thrombocyte Concentrate Transfusion. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Possible protective effect of pantoprazole against cisplatin-induced nephrotoxicity in head and neck cancer patients: a randomized controlled trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic optimisation of the treatment of peptic ulcer in patients with renal failure. [2018]

6. Austria pubmed.ncbi.nlm.nih.gov

Liver hepatotoxicity associated with pantoprazole: a rare case report. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Drug fever due to a single dose of pantoprazole. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Pantoprazole: a proton pump inhibitor with oral and intravenous formulations. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Radiation lethality potentiation in total body irradiated mice by a commonly prescribed proton pump inhibitor, Pantoprazole sodium. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Pantoprazole: an update of its pharmacological properties and therapeutic use in the management of acid-related disorders. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Pantoprazole-induced acute interstitial nephritis. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The protective effect of acute pantoprazole pretreatment on renal ischemia/reperfusion injury in rats. [2019]

13. Mexico pubmed.ncbi.nlm.nih.gov

[Superiority of pantoprazole over ranitidine in the treatment of duodenal ulcer. Mexican clinical experience. Mexican Study Group of Pantoprazole++ in Duodenal Ulcer]. [2018]

14. Canada pubmed.ncbi.nlm.nih.gov

Intravenous pantoprazole: a new tool for acutely ill patients who require acid suppression. [2019]