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Prevention and Treatment of Common Hyperglycemia in Surgery Pilot

NCT06624956 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-02-23

No results posted yet for this study

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

Interventions

DRUG

Crystalloid Infusion

placebo

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • David Flum, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2025-09-28
Completion
2026-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06624956 on ClinicalTrials.gov