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

Hyperglycemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167410
• Other study ID #: SBUniversitesi_nursing
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2020
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 1, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Perioperative Complication

Intervention

Other:
• 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. Data of the patients in the intervention group was collected after the patient applied to the hospital for surgery or just after the decision on surgery was taken. Patients in the intervention group whose HbA1C values exceeded 7% were referred to endocrinology specialists prior to surgery. Glycaemic management of these patients was evaluated at the department of endocrinology and medications or doses of insulin and oral antidiabetics were changed when necessary. Glycaemic management was conducted by nurses in line with the protocolConsequently, the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protocol.

Locations

Country	Name	City	State
Turkey	Gulhane Research and Training Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515. Review. Erratum in: Anesthesiology. 2018 Nov;129(5):1053. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of hyperglycaemia development	Capillary BG > 180 mg/dl refers to hyperglycemia.	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.
Primary	Insulin consumption rate	Insulin consumption of each participant was calculatedIn in the postoperative period.	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.
Primary	Rates of hypoglycaemia development	Capillary blood glucose (BG) < 70 mg/dl refers to hypoglycemia.	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.

External Links

•   American Diabetes Association