Prevention and Treatment of Common Hyperglycemia in Surgery Pilot

Completed · Phase 4 · Has a placebo group

Conditions studied: Surgery, Non Diabetic Hyperglycemia

In brief

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).

Key facts

Study ID

NCT06624956

Run by

University of Washington

People needed

106

Starts

2024-09-04

Expected to finish

2026-01-01

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years of age or older
• Patients undergoing abdominal surgery planned to last greater than 4 hours with inpatient admission
• Patients at UWMC - Montlake
• Makes their own medical decisions: patient is deemed to have decisional capacity by the medical team and does not have a surrogate such as a spouse, partner, or caretaker making the decision on their behalf. Examples include patients with severe dementia or other cognitive limitations

You may not qualify if…

• Known diagnosis of diabetes or altered glucose homeostasis during preoperative evaluation (single fasting blood sugar≥126 mg/dL or HbA1C≥6.5 percent).
• Known diagnosis of chronic kidney disease (moderate-to-severe, or worse)
• BMP within 6 months of screening is required. Patients with stage 3b (moderate-to-severe) kidney disease or worse (i.e. eGFR ≤ 30) will be excluded. Patients with a potassium reading greater than 5.5 at any point within the 6-month period will also be excluded.
• Patients receiving chronic systemic steroids.
• Patients undergoing cardiac or solid organ transplant procedures.
• Surgery planned to last less than 4 hours.
• Outpatient surgery
• Pregnant people
• Current UW Medicine or UW Dentistry residents and fellows
• Known hypersensitivity to potassium, glucose, insulin, or any of its excipients.
• Enrollment in another therapeutic study
• Any serious underlying medical or psychiatric condition, dementia, altered mental status or any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or that would confound the results of the study.

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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