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GIK Therapy for High Blood Sugar During Surgery (PATCHS Trial)

Phase 4
Waitlist Available
Led By David Flum, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing abdominal surgery planned to last greater than 4 hours with inpatient admission
Patients who make their own medical decisions and are deemed to have decisional capacity by the medical team without a surrogate making decisions on their behalf, e.g., patients with severe dementia or cognitive limitations
Must not have
Patients undergoing cardiac or solid organ transplant procedures
Outpatient surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial aims to see if using glucose, insulin, and potassium in non-diabetic patients undergoing abdominal surgery will reduce complications and death compared to standard treatment. They want to see if this treatment is feasible

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the exact side effects aren't listed here, treatments involving glucose, insulin, and potassium can typically cause changes in blood sugar levels, electrolyte imbalances, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for an abdominal surgery that will last more than 4 hours and require a hospital stay.
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I can make my own medical decisions without needing someone else to decide for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am undergoing a heart or organ transplant.
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My surgery will not require an overnight hospital stay.
Select...
I have diabetes or high blood sugar levels.
Select...
I am on long-term steroids.
Select...
My upcoming surgery is expected to take less than 4 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30-day Clinical NSQIP-defined serious adverse events
Ability to recruit the target population
Patient compliance/burden
+2 more
Secondary study objectives
Length of stay in hospital
Number of hyperglycemic and hypoglycemic events
Other study objectives
Postoperative inflammation

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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 Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,809 Previous Clinical Trials
1,913,371 Total Patients Enrolled
1 Trials studying Surgery
484 Patients Enrolled for Surgery
David Flum, MD, MPHPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
484 Total Patients Enrolled
1 Trials studying Surgery
484 Patients Enrolled for Surgery
~33 spots leftby Dec 2024
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