Prevention and Treatment of Common Hyperglycemia in Surgery Pilot

NCT06624956 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00019463
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Surgery; Non Diabetic Hyperglycemia

Outcome Measures

Primary Outcomes (5)

• 30-day Clinical NSQIP-defined serious adverse events

  Estimate the standard deviation in support of anticipated, large-scale RCT for the outcome 30-day Clinical NSQIP-defined serious adverse events

  30 days

• Patient compliance/burden

  Number patient refusal events vs enrolled

  1 day

• Ability to recruit the target population

  Number of patients screened per month vs number of patients enrolled per month

  1 day

• Provider compliance/burden

  Number of times GIK stopped for 20 minutes

  1

• Safety

  Number of AEs and SAEs, thought to be at least possibly related to treatment, as well as associated AE type

  1 day

Secondary Outcomes (2)

• Number of hyperglycemic and hypoglycemic events

  1 day

• Length of stay in hospital

  30 days

Other Outcomes (2)

• Postoperative inflammation

  1 day

• Postoperative inflammation

  1 day

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Subjects in the standard care/placebo arm will receive only regular crystalloid.

Drug: Crystalloid Infusion

GIK

ACTIVE COMPARATOR

Subjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added.

Drug: glucose, insulin, and potassium (GIK); Drug: Crystalloid Infusion

Interventions

glucose, insulin, and potassium (GIK) DRUG

GIK formulation: 100 g/L glucose, 33 U/L insulin, and 40 mmol/L KCl Reference PMID: 32151220. Formulation represents a 50% reduction in compounded solute combination from the reference study, which allows for administration via peripheral IV.

GIK

Crystalloid Infusion DRUG

placebo

GIK; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Zhao K, Zhang Y, Li J, Cui Q, Zhao R, Chen W, Liu J, Zhao B, Wan Y, Ma XL, Yu S, Yi D, Gao F. Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery. J Am Heart Assoc. 2020 Mar 17;9(6):e012376. doi: 10.1161/JAHA.119.012376. Epub 2020 Mar 10.

  PMID: 32151220 BACKGROUND

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  PMID: 26092476 BACKGROUND

MeSH Terms

Interventions

Glucose; Insulin; Potassium

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• David Flum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of General Surgery

Model Details: Potentially eligible patients will be approached on the day of surgery in a private room. Following formal, in person screening and informed consent by study team member who can thoroughly explain the study and answer patient questions, patients will be randomized to the study drug or to standard of care treatment (i.e. crystalloid infusion). All subjects will receive the same size bag of fluid and will have an infusion running during surgery. The administration of crystalloid is standard for surgeries performed at UW. Subjects in the standard/placebo arm will receive only regular crystalloid. Subjects in the GIK arm will receive regular crystalloid with GIK added. The contents of the bag will be blinded. The two fluids look the same to maintain blinding.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 3, 2024
• Study Start: September 4, 2024
• Primary Completion: September 28, 2025
• Study Completion: January 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)