100 Participants Needed

Pantoprazole for Acute Kidney Injury Prevention Post-Cardiac Surgery

YL
CR
Overseen ByConnor Rollings, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop taking my current medications for this trial?

The protocol does not specify if you need to stop taking your current medications. However, if you are taking proton pump inhibitors (PPIs) and have a hypersensitivity to them, you may be excluded from the trial.

What data supports the idea that Pantoprazole for Acute Kidney Injury Prevention Post-Cardiac Surgery is an effective drug?

The available research does not provide any data on Pantoprazole for preventing acute kidney injury after cardiac surgery. Instead, the studies focus on different treatments related to organ transplantation, such as immunosuppressive drugs used to prevent organ rejection. Therefore, there is no information here to support the effectiveness of Pantoprazole for this specific use.12345

What safety data exists for pantoprazole in preventing acute kidney injury after cardiac surgery?

The provided research does not directly address the safety of pantoprazole for preventing acute kidney injury post-cardiac surgery. However, pantoprazole is a proton pump inhibitor with established use in treating acid-related diseases and has been compared to other treatments like ranitidine and omeprazole in various studies. These studies focus on its efficacy and safety in treating gastrointestinal conditions, but specific safety data for its use in preventing acute kidney injury post-cardiac surgery is not available in the provided research.678910

Is the drug Pantoprazole promising for preventing kidney injury after heart surgery?

Pantoprazole is known for reducing stomach acid, which can be helpful in treating stomach issues. However, its role in preventing kidney injury after heart surgery is not clearly supported by the research provided.89111213

What is the purpose of this trial?

The purpose of this study is to determine whether perioperative intravenous administration of pantoprazole will improve kidney function parameters following cardiac surgery with cardiopulmonary bypass compared to famotidine and to determine whether perioperative intravenous administration of pantoprazole will decrease the incidence of postoperative Acte Kidney Injury (AKI) and major adverse kidney events (MAKE).

Research Team

YL

Yafen Liang, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults scheduled for elective cardiac surgery with a high risk of acute kidney injury (AKI), as indicated by a Cleveland risk score over 6. They must have normal preoperative kidney function and not be on dialysis, pregnant, nursing, allergic to PPIs, or have liver disease or vitamin B12 deficiency.

Inclusion Criteria

I am scheduled for heart surgery with a high risk of kidney injury.

Exclusion Criteria

I need surgery urgently.
I have a liver condition.
I depend on dialysis for kidney function.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pantoprazole or famotidine perioperatively for 2 days

2 days
In-hospital during surgery

Immediate Postoperative Monitoring

Monitoring of kidney injury biomarkers (KIM-1 and NGAL) at 8, 24, and 48 hours postoperatively

48 hours

Follow-up

Participants are monitored for major adverse kidney events and AKI incidence up to 30 days post-surgery

30 days

Treatment Details

Interventions

  • Famotidine
  • Pantoprazole
Trial Overview The study tests if intravenous pantoprazole can improve kidney function and reduce AKI after heart surgery using cardiopulmonary bypass compared to famotidine. It also looks at the effect on major adverse kidney events.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pantoprazole groupExperimental Treatment1 Intervention
Pantoprazole (40 mg iv every 12 hours/q12H) for 2 days perioperatively (first dose after anesthesia induction and before surgical incision, second dose at chest closure, then followed by 2 doses daily (Q12hr dosing) on postoperative (POD) 1 for a total of 4 doses over 2 days. There will be no other modifications in patient care.
Group II: Famotidine GroupActive Control1 Intervention
Famotidine (20 mg iv q12H) for 2 days perioperatively (first dose after anesthesia induction and before surgical incision, second dose at chest closure, then followed by 2 doses daily (Q12hr dosing) on POD 1 for a total of 4 doses over 2 days. There will be no other modifications in patient care.

Famotidine is already approved in United States, European Union, Canada, Japan for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Pepcid for:
  • Gastroesophageal reflux disease (GERD)
  • Zollinger-Ellison syndrome
  • Peptic ulcer disease
πŸ‡ͺπŸ‡Ί
Approved in European Union as Famotidine for:
  • Gastroesophageal reflux disease (GERD)
  • Zollinger-Ellison syndrome
  • Peptic ulcer disease
πŸ‡¨πŸ‡¦
Approved in Canada as Pepcid for:
  • Gastroesophageal reflux disease (GERD)
  • Zollinger-Ellison syndrome
  • Peptic ulcer disease
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Approved in Japan as Famotidine for:
  • Gastroesophageal reflux disease (GERD)
  • Zollinger-Ellison syndrome
  • Peptic ulcer disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Society of Cardiovascular Anesthesiologists

Collaborator

Trials
3
Recruited
5,600+

Findings from Research

In a study of 50 patients undergoing simultaneous pancreas-kidney (SPK) transplantation, a quadruple immunosuppressive regimen including rabbit antithymocyte globulin (ATG) significantly reduced the incidence of acute renal rejection episodes compared to a triple regimen with cyclosporine (CsA), azathioprine, and corticosteroids (36% vs. 76%).
Despite a higher rate of adverse events in the ATG group (80% vs. 40%), none led to drug discontinuation, and there were no differences in overall patient, pancreas, or kidney survival rates between the two treatment groups.
Randomized comparison of triple therapy and antithymocyte globulin induction treatment after simultaneous pancreas-kidney transplantation.Cantarovich, D., Karam, G., Giral-Classe, M., et al.[2013]
In a study of 136 simultaneous pancreas-kidney transplant recipients, alemtuzumab was found to significantly reduce the incidence of acute cellular rejection (ACR) compared to basiliximab (3.1% vs. 12.8% over 2 years), indicating its efficacy in preventing this type of rejection.
While both induction agents showed similar rates of antibody-mediated rejection (AMR), the study revealed that AMR was more common in patients treated with alemtuzumab, highlighting a complex balance in rejection types and suggesting that while ACR is better managed with alemtuzumab, AMR remains a concern.
Alemtuzumab induction and antibody-mediated kidney rejection after simultaneous pancreas-kidney transplantation.Pascual, J., Pirsch, JD., Odorico, JS., et al.[2017]
Over the past decade, there has been a significant shift in immunosuppression strategies for solid-organ transplantation, with a notable increase in the use of induction therapy using antibodies, particularly among kidney and pancreas transplant recipients.
The combination of tacrolimus and mycophenolate mofetil has become the most common discharge regimen, and there is a growing trend towards steroid-avoidance protocols, contributing to a decline in acute rejection rates post-transplantation.
Immunosuppression: evolution in practice and trends, 1994-2004.Meier-Kriesche, HU., Li, S., Gruessner, RW., et al.[2023]

References

Randomized comparison of triple therapy and antithymocyte globulin induction treatment after simultaneous pancreas-kidney transplantation. [2013]
Alemtuzumab induction and antibody-mediated kidney rejection after simultaneous pancreas-kidney transplantation. [2017]
Immunosuppression: evolution in practice and trends, 1994-2004. [2023]
Simultaneous pancreas-kidney transplantation in the United States: an analysis of the UNOS registry. [2011]
The comparative efficacy and safety of basiliximab and antithymocyte globulin in deceased donor kidney transplantation: a multicenter cohort study. [2023]
[Superiority of pantoprazole over ranitidine in the treatment of duodenal ulcer. Mexican clinical experience. Mexican Study Group of Pantoprazole++ in Duodenal Ulcer]. [2018]
Upper gastrointestinal complications after renal transplantation: a 3-yr sequential study. [2019]
A double-blind study of pantoprazole and omeprazole in the treatment of reflux oesophagitis: a multicentre trial. [2019]
Pantoprazole versus omeprazole in the treatment of acute gastric ulcers. [2019]
Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. [2018]
Safety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis-a 2-year follow-up. [2022]
Association Between Proton Pump Inhibitor Exposure and Acute Kidney Injury After Cardiac Surgery. [2023]
Proton pump inhibitors and traditional nonsteroidal anti-inflammatory drugs and the risk of acute interstitial nephritis and acute kidney injury. [2016]
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