Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-21
Brief Title:
SHOrt-term Glycemic Control for Reducing Post-SURGical Complications
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Surg-ShoGR
Brief Summary:
Perioperative dysglycemia-hyperglycemia hypoglycemia and glycemic variability-is associated with an increased risk for adverse outcomes Several studies have reported the association between elevated preoperative HbA1c and postoperative complications
There are no studies that confirm that postponing elective surgery improves patient outcomes Likewise no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries
Consequently we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality
There are no studies that confirm that postponing elective surgery improves patient outcomes Likewise no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries
Consequently we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality
Detailed Description:
Despite the limitations of measurements of HbA1c guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels 7-85 Joshi et al 2010 CPOC 2022 However no studies confirm that postponing elective surgery improves patient outcomes Likewise no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries Duggan et al 2017
Consequently we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality We hypothesize that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is 75 58 mmolmol short-term glycemic control would improve outcome compared to standard-of-care as measured with days-at-home at 30 postoperative days DAH-30
The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients preoperative HbA1c 75 58 mmolmol for reducing postoperative morbidity and mortality
The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups
1 Short-term glycemic control group
Patients will be admitted to the hospital for 2-3 days before surgery During this pilot study patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose We aim to maintain moderate glucose control 140 - 180 mgdl using basal-bolus insulin protocol plus correctional doses as needed
2 Standard-of-care group Patients will be admitted the day before surgery with the usual patient treatment
In both groups diabetic drugs will be managed per local protocol
Consequently we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality We hypothesize that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is 75 58 mmolmol short-term glycemic control would improve outcome compared to standard-of-care as measured with days-at-home at 30 postoperative days DAH-30
The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients preoperative HbA1c 75 58 mmolmol for reducing postoperative morbidity and mortality
The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups
1 Short-term glycemic control group
Patients will be admitted to the hospital for 2-3 days before surgery During this pilot study patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose We aim to maintain moderate glucose control 140 - 180 mgdl using basal-bolus insulin protocol plus correctional doses as needed
2 Standard-of-care group Patients will be admitted the day before surgery with the usual patient treatment
In both groups diabetic drugs will be managed per local protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None