Prevention and Treatment of Common Hyperglycemia in Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2026-04-01

Brief Summary

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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 \&amp; 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).

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Detailed Description

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Elevated glucose levels during surgery are common and dramatically increase the risk of morbidity and mortality. This has been identified in multiple statewide quality improvement collaboratives, with a monotonic relationship between increased glucose levels and higher risks of almost all adverse events. While perioperative glucose management tends to focus on those with diabetes, some degree of perioperative hyperglycemia occurs in as much as two thirds of non-diabetic patients.

A recently identified phenomenon is that, at the same levels of hyperglycemia, non-diabetic patients have a much greater risk of death and complications compared to patients with diabetes. Given that hyperglycemia is typically considered a problem for people with diabetes, this finding has been described as a hyperglycemia paradox. Unfortunately, treatment with insulin can only happen after hyperglycemia has been recognized, and since non-diabetic patients are often not monitored for hyperglycemia, hyperglycemia is likely to be under-recognized. Moreover, addressing hyperglycemia after the fact may not be as effective in reducing adverse events as preventing hyperglycemia.

There is a long history of using perioperative insulin in patients undergoing at least one type of surgery. For over 45 years cardiac anesthesiologists have been testing the benefits of insulin combined with glucose and potassium (GIK) in cardiac surgery. In more than 30 RCTs, including more than 2000 patients with and without diabetes, GIK prophylaxis has been shown to be safe, with \&lt; 1 in 200 participants experiencing hypoglycemia secondary to the inclusion of glucose in the formulation. Moreover, these studies have found large reductions in surgically induced inflammation and often significant improvements in clinical outcomes.

Conditions

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Surgery Non Diabetic Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Care

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

Group Type PLACEBO_COMPARATOR

Crystalloid Infusion

Intervention Type DRUG

placebo

GIK

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

Group Type ACTIVE_COMPARATOR

glucose, insulin, and potassium (GIK)

Intervention Type 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.

Crystalloid Infusion

Intervention Type DRUG

placebo

Interventions

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glucose, insulin, and potassium (GIK)

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.

Intervention Type DRUG

Crystalloid Infusion

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults 18 years of age or older
2. Patients undergoing abdominal surgery planned to last greater than 4 hours with inpatient admission
3. Patients at UWMC - Montlake

3\. 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

Exclusion Criteria

1. Known diagnosis of diabetes or altered glucose homeostasis during preoperative evaluation (single fasting blood sugar≥126 mg/dL or HbA1C≥6.5 percent).
2. 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.
3. Patients receiving chronic systemic steroids.
4. Patients undergoing cardiac or solid organ transplant procedures.
5. Surgery planned to last less than 4 hours.
6. Outpatient surgery
7. Pregnant people
8. Current UW Medicine or UW Dentistry residents and fellows
9. Known hypersensitivity to potassium, glucose, insulin, or any of its excipients.
10. Enrollment in another therapeutic study
11. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No