SurgeryPhase 4PATCHS PilotNCT06624956
Prevention and Treatment of Common Hyperglycemia in Surgery Pilot
A Phase 4 study testing glucose, insulin, and potassium (GIK) and Crystalloid Infusion in people with Surgery and Non Diabetic Hyperglycemia, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Non Diabetic Hyperglycemia
- What is being tested?
- glucose, insulin, and potassium (GIK) and Crystalloid Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Prevention and Treatment of Common Hyperglycemia in Surgery (PATCHS): A Randomized, Controlled, Pilot Study
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).
Read the detailed description
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 \< 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
- Surgery, Non Diabetic Hyperglycemia
- Being tested
- glucose, insulin, and potassium (GIK), Crystalloid Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Crystalloid InfusionDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | Subjects in the standard care/placebo arm will receive only regular crystalloid. Receives: Drug: Crystalloid Infusion |
| GIK | Active comparator | Subjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added. Receives: Drug: glucose, insulin, and potassium (GIK); Drug: Crystalloid Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Patient compliance/burden
Number patient refusal events vs enrolled
Measured: 1 day
Ability to recruit the target population
Number of patients screened per month vs number of patients enrolled per month
Measured: 1 day
Provider compliance/burden
Number of times GIK stopped for 20 minutes
Measured: 1
Safety
Number of AEs and SAEs, thought to be at least possibly related to treatment, as well as associated AE type
Measured: 1 day
Secondary outcomes (2)
Number of hyperglycemic and hypoglycemic events
hyper- (BG>180) and hypoglycemic (BG <70)
Measured: 1 day
Length of stay in hospital
Defined in post-op days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start4 Sep 2024
- Primary completion28 Sep 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David Flum, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624956
- Sponsor's protocol ID
- STUDY00019463
- Acronym
- PATCHS Pilot
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32151220Whitehead 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.
PubMed 26092476
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Common Hyperglycemia in Surgery (PATCHS): A Randomized, Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT06624956
- Acronym / sponsor ID
- PATCHS Pilot / STUDY00019463
- Conditions
- Surgery, Non Diabetic Hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Drug: Crystalloid InfusionSubjects in the standard care/placebo arm will receive only regular crystalloid. |
| GIK | Active comparator | Drug: glucose, insulin, and potassium (GIK), Drug: Crystalloid InfusionSubjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (12 listed)
- 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)
- Patients receiving chronic systemic steroids.
- Patients undergoing cardiac or solid organ transplant procedures.
- Surgery planned to last less than 4 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | GIK |
| Crystalloid Infusionplacebo | Drug | GIK, Standard Care |
Primary outcome
30-day Clinical NSQIP-defined serious adverse events
Time frame: 30 days
Estimate the standard deviation in support of anticipated, large-scale RCT for the outcome 30-day Clinical NSQIP-defined serious adverse events
Patient compliance/burden
Time frame: 1 day
Number patient refusal events vs enrolled
Ability to recruit the target population
Time frame: 1 day
Number of patients screened per month vs number of patients enrolled per month
Provider compliance/burden
Time frame: 1
Number of times GIK stopped for 20 minutes
Safety
Time frame: 1 day
Number of AEs and SAEs, thought to be at least possibly related to treatment, as well as associated AE type
2 secondary outcomes
Number of hyperglycemic and hypoglycemic events
Time frame: 1 day
Length of stay in hospital
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 32151220Zhao 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.
- Background: PubMed 26092476Whitehead 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Flum, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing glucose, insulin, and potassium (GIK) and Crystalloid Infusion in people with Surgery and Non Diabetic Hyperglycemia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Clinical NSQIP-defined serious adverse events (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.