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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment GIK for high blood sugar during surgery?

Research shows that GIK treatment can improve heart function and recovery after heart surgery, especially in diabetic patients. It helps by reducing heart stress and improving outcomes during and after surgery. ^{1 2 3 4 5}

Is GIK therapy safe for use in humans?

GIK therapy has been studied in patients undergoing heart surgeries, and it has been shown to reduce major heart-related complications without increasing blood sugar levels, suggesting it is generally safe for use in humans. ^{1 2 3 4 6}

How does GIK treatment for high blood sugar during surgery differ from other treatments?

GIK treatment is unique because it combines glucose, insulin, and potassium to manage blood sugar levels during surgery, potentially improving heart function and reducing complications. Unlike standard treatments, GIK may enhance tissue perfusion and myocardial metabolism, offering additional cardiovascular benefits. ^{1 3 6 7 8}

What is the purpose of this trial?

The PATCH pilot trial aims to establish feasibility and determine the sample size of a future, large-scale, multi-site RCT, as well as reinforce the long-standing known safety profile of glucose, insulin, and potassium (GIK) and explore the physiologic response. We hypothesize that the use of GIK in non-diabetic patients undergoing abdominal surgery, will reduce rates of morbidity \& death compared to standard of care treatment. In brief, primary outcomes of interest include estimation of the standard deviation (to derive a sample size estimation) and the ability to recruit target population, assessment of patient compliance/burden, and assessment of provider compliance/burden (feasibility).

Research Team

David Flum, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

My surgery will not require an overnight hospital stay.

Enrollment in another therapeutic study

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Iran pubmed.ncbi.nlm.nih.gov

Efficacy of Glucose-Insulin-Potassium Infusion on Left Ventricular Performance in Type II Diabetic Patients Undergoing Elective Coronary Artery Bypass Graft.Dy. [2021]

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

Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events. [2022]

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

Diastolic dysfunction after coronary artery bypass grafting--the effect of glucose-insulin-potassium infusion. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Glucose-insulin-potassium in cardiac surgery: a meta-analysis. [2013]

5. China pubmed.ncbi.nlm.nih.gov

[Effect of perioperative glucose-insulin-potassium infusions on the prognosis in patients undergoing coronary artery bypass grafting: a meta-analysis]. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Management of diabetes during surgery with glucose-insulin-potassium infusion. [2019]

8. Croatia pubmed.ncbi.nlm.nih.gov

The importance of glucose-insulin-potassium with cardiopulmonary bypass prior to cardioplegic arrest in open-heart surgery. [2013]