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

Effects of Perioperative Glycemic Management Protocol on Glycemic Outcomes of Type 2 Diabetic Patients Undergoing Major Abdominal Surgery: a Non-Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Perioperative Complication
• Intervention / Treatment: Other: glycaemic management protocol implemented to clinic

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Gülhane Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; We did not perform any intervention on the patients in the control group. These patients received routine glycaemia control and healthcare provided to diabetic patients undergoing surgical intervention in the department of general surgery.After receiving written informed consent, the first part of the data collection form on the socio-demographic and disease characteristics of the patients were completed face-to-face. The BG levels of the patients and the medications and insulin used for glycaemic control were recorded one night before surgery. The anxiety levels of the patients were evaluated on the morning of surgery using State-Trait Anxiety Inventory . The second part of the data collection form , which included information on glycaemic management, glycaemia levels and the medications and insulin used on the morning of surgery and during surgery, intensive care stay and the clinical period, was filled in by the nurse on the monitoring and anaesthesia forms.
Experimental: intervention group; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Investigators: Principal Investigator: Pervin Kurtoglu, PhD, GulhaneResearch and Training Hospital

Publications and helpful links

General Publications

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

Helpful Links

• American Diabetes Association

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Nursing; Stress hyperglycaemia; Perioperative glycaemic management; Glycaemic protocol; Glycaemic management; Surgery and diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: SBUniversitesi_nursing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De identifield individual participant data for all primary and secondary outcomes measures will be made available
• IPD Sharing Time Frame: data will be available within 2 years of study completion
• IPD Sharing Access Criteria: the data of study will be requested from the principle researcher by mail
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No