GIK Therapy for High Blood Sugar During Surgery

(PATCHS Trial)

Overseen By Sara DePaoli

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Washington

Must not be taking: Systemic steroids

Disqualifiers: Diabetes, Chronic kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment method called GIK, which stands for glucose, insulin, and potassium, to manage high blood sugar in non-diabetic patients during abdominal surgery. Researchers aim to determine if GIK can reduce complications or death compared to usual care. Suitable candidates for this trial are those planning abdominal surgery expected to last over four hours and who can make their own medical decisions. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic systemic steroids, you would be excluded from participating.

What is the safety track record for GIK therapy?

Research has shown that GIK therapy, which combines glucose, insulin, and potassium, has been studied for its effects on heart health, particularly during surgeries. Some studies found that GIK can reduce major heart issues and aid in heart recovery post-surgery. It seems to lower the risk of heart attacks (when blood flow to the heart is blocked) and improve blood flow during surgery.

Overall, these studies suggest that GIK is generally safe and well-tolerated for surgical patients. However, the benefits can vary depending on the type of surgery and the patient's condition. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the GIK therapy because it combines glucose, insulin, and potassium to manage high blood sugar during surgery. Unlike typical treatments that might only focus on insulin to control blood sugar levels, GIK therapy provides a balanced approach by adding glucose and potassium, potentially stabilizing blood sugar more effectively. This combination could improve patient outcomes by maintaining metabolic balance during surgery, which is crucial for recovery and overall surgical success.

What evidence suggests that GIK therapy might be an effective treatment for high blood sugar during surgery?

Research has shown that glucose-insulin-potassium (GIK) therapy can be beneficial during surgery. In this trial, participants in the GIK arm will receive regular crystalloid with GIK added. Studies have found that GIK reduces the risk of heart attacks and improves heart function in patients undergoing heart surgery. It also decreases heart damage and enhances heart performance afterward. GIK therapy has been used safely in similar situations, suggesting it could help manage high blood sugar during surgery. These findings indicate that GIK might make surgery safer by protecting the heart and ensuring better blood flow. ^{1 2 3 6 7}

Who Is on the Research Team?

David Flum, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for non-diabetic individuals who are about to undergo abdominal surgery and may be at risk of high blood sugar. Participants should not have diabetes but could have prediabetes or a history of high blood sugar levels.

Inclusion Criteria

I am scheduled for an abdominal surgery that will last more than 4 hours and require a hospital stay.

Patients at UWMC - Montlake

I can make my own medical decisions without needing someone else to decide for me.

Exclusion Criteria

Pregnant people

Enrollment in another therapeutic study

My surgery will not require an overnight hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care with regular crystalloid or GIK (glucose, insulin, and potassium) added to regular crystalloid during surgery

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of serious adverse events and compliance

30 days

What Are the Treatments Tested in This Trial?

Interventions

• GIK

Trial Overview The PATCH pilot trial is testing the safety and response to a treatment combining glucose, insulin, and potassium (GIK) in patients having abdominal surgery. It compares this GIK treatment with standard care to see if it reduces complications or death.

How Is the Trial Designed?

Group I: GIK Active Control 2 Interventions

Subjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added.

Group II: Standard Care Placebo Group 1 Intervention

Subjects in the standard care/placebo arm will receive only regular crystalloid.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3641560/

Hyperglycemia and Perioperative Glucose Management Use of insulin therapy to improve outcomes during critical illness began with the use of glucose-insulin-potassium (GIK) infusions for treatment of myocardial ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1043067922002623

Cardioprotective Effects of Glucose-Insulin-Potassium ... The infusion of glucose-insulin-potassium lowers the risk of myocardial infarction while enhancing hemodynamics in patients undergoing on-pump cardiac surgery.

3. academic.oup.com academic.oup.com/ejcts/article/40/1/192/600930

Glucose–insulin–potassium therapy in adult patients ... The results of our meta-analysis confirmed that GIK was associated with reduced myocardial injury and better postoperative hemodynamic performance in cardiac ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.012376

Modified Glucose‐Insulin‐Potassium Regimen Provides ... GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3347817/

Efficacy of Glucose-Insulin-Potassium Infusion on Left ... Glucose-insulin-potassium (GIK) may improve cardiovascular performance after coronary artery bypass graft surgery (CABG). Our study investigated whether an ...

6. journal.hsforum.com journal.hsforum.com/index.php/HSF/article/download/2735/4279/17977

Effect of Perioperative Glucose-Insulin-Potassium Therapy ... The aim of this meta-analysis was to evaluate the effect of GIK therapy on outcomes in patients undergoing on-pump cardiac surgery. Methods: A comprehensive ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/209584

Glucose-Insulin-Potassium Therapy in Patients With ST ... The clinical benefit of glucose-insulin-potassium (GIK) infusion in patients with ST-segment elevation myocardial infarction (STEMI) is unclear.