Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery

Not Applicable

Completed

• Conditions: Hyperglycemia; Perioperative Complication
• Interventions: Other: glycaemic management protocol implemented to clinic

• Registration Number: NCT04167410
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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.

Study Timeline

• Study Start: 2017-09-15
• Primary Completion: 2018-12-15
• Study Completion: 2019-03-01
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
intervention group	glycaemic management protocol implemented to clinic	Following the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. management was conducted by nurses in line with the protocol. Data on glycaemic management of the intervention group was similar to the control group.the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protoco

Primary Outcome Measures

Name	Time	Method
Rates of hyperglycaemia development	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.	Capillary BG \> 180 mg/dl refers to hyperglycemia.
Insulin consumption rate	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.	Insulin consumption of each participant was calculatedIn in the postoperative period.
Rates of hypoglycaemia development	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.	Capillary blood glucose (BG) \< 70 mg/dl refers to hypoglycemia.

Trial Locations

Locations (1)

Gulhane Research and Training Hospital; 🇹🇷 Ankara, Turkey