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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04167410
Other study ID # SBUniversitesi_nursing
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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