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).
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.
I can make my own medical decisions without needing someone else to decide for me.
Exclusion Criteria
I am undergoing a heart or organ transplant.
My surgery will not require an overnight hospital stay.
I have diabetes or high blood sugar levels.
I am on long-term steroids.
My upcoming surgery is expected to take less than 4 hours.
Treatment Details
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.
2Treatment groups
Active Control
Placebo Group
Group I: GIKActive Control2 Interventions
Subjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added.
Group II: Standard CarePlacebo Group1 Intervention
Subjects in the standard care/placebo arm will receive only regular crystalloid.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Washington Medical CenterSeattle, WA
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Who is running the clinical trial?
University of WashingtonLead Sponsor