Clinical trial NCT04167410: Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery
Official title: Effects of Perioperative Glycemic Management Protocol on Glycemic Outcomes of Type 2 Diabetic Patients Undergoing Major Abdominal Surgery: a Non-Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Perioperative Complication
Keywords: Perioperative glycaemic management
Nursing
Glycaemic protocol
Glycaemic management
Stress hyperglycaemia
Surgery and diabetes
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study evaluated to the effects of a glycaemic control protocol directed by nurses during the perioperative period on glycaemic outcomes in diabetic patients undergoing major abdominal surgery. The study was conducted at the department of general surgery of a research and training hospital.The study included 47 patients who underwent elective major abdominal surgery between September 2017 and December 2018. The number of patients in the intervention and the control groups was 22 and 25, respectively. The glycemia control protocol will be used in the glycemia management of intervention group,routine glycemia management will be used in the control group.

Detailed description: The prevalence of diabetes among the surgical patient population is 10-15%, and surgical operations are administered to diabetic patients more frequently compared to non-diabetic patients. Diabetes or hyperglycaemia in surgical patients increases mortality and morbidity rates during the perioperative period by 50% compared to non-diabetic patients. Maintaining patient blood glucose (BG) levels of within the target range during the surgical period is crucial to prevent postoperative complications. The target BG level has been modified in line with recent scientific findings; institutions (such as the American Diabetes Association), have prepared new guidelines for the management of glycaemia in critically ill and surgical patients. Insulin infusion is the most effective method to control glycaemia in patients with critical disease or in patients about to undergo major surgery. Therefore, current guidelines recommend the use of reliable and practical glycaemia control protocols during insulin infusion. These protocols should be learnt by all members of the team that provide healthcare. Existing studies suggest that glycaemic management protocols are effective methods to achieve the target BG range and decrease the prevalence of hyperglycaemia and hypoglycaemia in critically ill and major surgery patients in a reliable and effective way.

Eligibility criteria: Inclusion Criteria;

* Patients were diagnosed with type 2 diabetes
* Patients planned to undergo elective major abdominal surgery

Exclusion Criteria;

* Patients who had diabetes other than type 2 diabetes
* Patient who had a preoperative glycated haemoglobin A1C (HbA1C) value of 8.5% or greater
* Patient planned to undergo surgery related to the pancreas

Primary outcomes:
measure: Rates of hyperglycaemia development
timeFrame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
measure: Insulin consumption rate
timeFrame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
measure: Rates of hypoglycaemia development
timeFrame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Research and Training Hospital
Study officials:
affiliation: GulhaneResearch and Training Hospital
name: Pervin Kurtoglu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Compton F, Ahlborn R, Weidehoff T. Nurse-Directed Blood Glucose Management in a Medical Intensive Care Unit. Crit Care Nurse. 2017 Jun;37(3):30-40. doi: 10.4037/ccn2017922.
citation: Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515.