SHOrt-term Glycemic Control for Reducing Post-SURGical Complications

Diabetes Clinical Trial

— Surg-ShoGR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334068
• Other study ID #: MS.24.03.2725
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: Moataz M Emara, MD, EDAIC
• Phone: 01064048848
• Email: mm.emara[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (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 ≥7.5% (≥58 mmol/mol), 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 ≥7.5% [≥58 mmol/mol]) 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 mg/dl) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all adult diabetic patients (=18 years) of either sex scheduled for major abdominal surgery (estimated operative time is > 2 hours) with Hb A1c =7.5% (58 mmol/mol).

Exclusion Criteria:

• Patients < 18 years
• Emergency Surgery
• Elective surgery that can be postponed safely till glycemic control
• Hb A1c < 7.5%
• Pregnant patients
• Patient Refusal

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• 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 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed.
• Standard-of-care group
Patients will be admitted the day before surgery with the usual patient treatment.

Locations

Country	Name	City	State
Egypt	Moataz Maher Emara	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to resumption of normal diabetes therapy	number in days	60 days after surgery
Other	Incidence of diabetic ketoacidosis or hypoglycemia	incidence (yes/no) outcome	during the hospitalization period (within 30 days after surgery)
Other	Incidence of use of intravenous insulin infusion therapy	incidence (yes/no) outcome	during the hospitalization period (within 30 days after surgery)
Other	Duration of use of intravenous insulin infusion therapy	duration in days and hours	during the hospitalization period (within 30 days after surgery)
Other	Change in diabetic management at 30 days	incidence (yes/no) outcome	during the hospitalization period (after 30 days after surgery)
Primary	Number of days at home after surgery (DAH-30).	Continuous outcome as the number of days over the 30 days after surgery.	30 days after surgery
Secondary	Loss of follow-up after surgery	Incidence (yes/no) outcome	30 days after Surgery
Secondary	Loss of follow up after the clinic preoperative assessment	incidence (yes/no) outcome	30 days after initial assessment
Secondary	30-day mortality	incidence (yes/no) outcome	30 days after surgery
Secondary	Length of hospital stay	continuous outcome: number of days untill discharge from hospital after surgery	30 days after surgery
Secondary	incidence of postoperative complications	according to the comprehensive complications index (Kalt et al., 2023)	30 days after surgery
Secondary	Quality of Recovery15 (QoR-15)	a score of 15 items	after 24 hours of surgery