GIK Therapy for High Blood Sugar During Surgery

(PATCHS Trial)

Overseen By Sara DePaoli

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Washington

Prior Safety Data

Trial Summary

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 18 years old or older.

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

Patients at UWMC - Montlake

Exclusion Criteria

Pregnant people

My surgery will not require an overnight hospital stay.

Enrollment in another therapeutic study

Treatment Details

Interventions

• GIK (Other)

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+