Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624956
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Prevention and Treatment of Common Hyperglycemia in Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention and Treatment of Common Hyperglycemia in Surgery PATCHS a Randomized Controlled Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATCHS
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 ampamp 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 complianceburden and assessment of provider complianceburden 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 amplt 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
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 amplt 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None