Clinical trial NCT06334068: SHOrt-term Glycemic Control for Reducing Post-SURGical Complications
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Uncontrolled Diabtetes
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients in the preoperative anesthesia clinic are divided into one of the following 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days at home after surgery (DAH-30).
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Loss of follow-up after surgery
timeFrame: 30 days after Surgery
measure: Loss of follow up after the clinic preoperative assessment
timeFrame: 30 days after initial assessment
measure: 30-day mortality
timeFrame: 30 days after surgery
measure: Length of hospital stay
timeFrame: 30 days after surgery
measure: incidence of postoperative complications
timeFrame: 30 days after surgery
measure: Quality of Recovery15 (QoR-15)
timeFrame: after 24 hours of surgery
Other outcomes:
measure: Time to resumption of normal diabetes therapy
timeFrame: 60 days after surgery
measure: Incidence of diabetic ketoacidosis or hypoglycemia
timeFrame: during the hospitalization period (within 30 days after surgery)
measure: Incidence of use of intravenous insulin infusion therapy
timeFrame: during the hospitalization period (within 30 days after surgery)
measure: Duration of use of intravenous insulin infusion therapy
timeFrame: during the hospitalization period (within 30 days after surgery)
measure: Change in diabetic management at 30 days
timeFrame: during the hospitalization period (after 30 days after surgery)
Locations:
city: Mansoura
country: Egypt
facility: Moataz Maher Emara
state: Aldakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Moataz M Emara, MD, EDAIC
role: PRINCIPAL_INVESTIGATOR
References: