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

Primary Purpose

Hyperglycemia, Perioperative Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
glycaemic management protocol implemented to clinic
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperglycemia focused on measuring Perioperative glycaemic management, Nursing, Glycaemic protocol, Glycaemic management, Stress hyperglycaemia, Surgery and diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gulhane Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 15, 2019
Last Updated
January 21, 2020
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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1. Study Identification

Unique Protocol Identification Number
NCT04167410
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Perioperative Complication
Keywords
Perioperative glycaemic management, Nursing, Glycaemic protocol, Glycaemic management, Stress hyperglycaemia, Surgery and diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
glycaemic management protocol implemented to clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of hyperglycaemia development
Description
Capillary BG > 180 mg/dl refers to hyperglycemia.
Time Frame
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.
Title
Insulin consumption rate
Description
Insulin consumption of each participant was calculatedIn in the postoperative period.
Time Frame
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.
Title
Rates of hypoglycaemia development
Description
Capillary blood glucose (BG) < 70 mg/dl refers to hypoglycemia.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pervin Kurtoglu, PhD
Organizational Affiliation
GulhaneResearch and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Research and Training Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
28572099
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.
Results Reference
background
PubMed Identifier
28121636
Citation
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.
Results Reference
background
Links:
URL
https://doi.org/10.2337/dc17-S017
Description
American Diabetes Association

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

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