COMPAS studie

the effect of continuous glucose monitoring in patients with diabetes undergoing major surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24618

Enrollment

Registered

2014-12-17

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus perioperative period continuous glucose sensor

Interventions

use of continuous glucose sensor in the perioperative period

Eligibility

Inclusion criteria

Inclusion criteria: - Aged 18-85 - Able to give written informed consent - Laparotomy or cardiac surgery with planned postoperative stay at PACU or Will receive an arterial line for standard patient care

Exclusion criteria

Exclusion criteria: - Any condition that the local investigator feels would interfere with trial participation or the evaluation of results - Allergy for heparin - Known HIT - Total pancreatectomy

Design outcomes

Primary

Measure	Time frame
The difference in median glucose 1 hour after surgery will be calculated as a measure of glycaemic control during surgery. Furthermore, the difference in proportion of time spent in the target range, time spent above the target range and time spent below the target range between groups will be calculated.	—

Secondary

Measure	Time frame
The secondary outcome measure include the accuracy of the GCM, measured by the mean absolute relative difference (MARD= (CGM value−POC/POC)). Furthermore a Clarke error grid and Bland-Altman analyses, MARD in the lower glycaemic (glucose 10 mmol/l) ranges. The ranges are according to the AMC protocol. The MARD during cardiopulmonary bypass and during the use of vasopressors will also be calculated. We will record the number of false alarms, the number of times the intravenous line has to be replaced due to failure of the device or clotting error. Also, the glucose variability, the amount of insulin used and the occurrence hypoglycaemic events (glucose < 4.0 mmol/l) and severe hypoglycaemia (glucose <2.3 mmol/l) will be compared between groups. Glucose variability will be expressed as mean absolute glucose change (MAG) per hour18. The difference in occurrence of postoperative complications will be assessed according to Dindo-Clavien grading system19 30 days after surgery.	—

Measure

Time frame

The secondary outcome measure include the accuracy of the GCM, measured by the mean absolute relative difference (MARD= (CGM value−POC/POC)). Furthermore a Clarke error grid and Bland-Altman analyses, MARD in the lower glycaemic (glucose 10 mmol/l) ranges. The ranges are according to the AMC protocol. The MARD during cardiopulmonary bypass and during the use of vasopressors will also be calculated. We will record the number of false alarms, the number of times the intravenous line has to be replaced due to failure of the device or clotting error. Also, the glucose variability, the amount of insulin used and the occurrence hypoglycaemic events (glucose < 4.0 mmol/l) and severe hypoglycaemia (glucose <2.3 mmol/l) will be compared between groups. Glucose variability will be expressed as mean absolute glucose change (MAG) per hour18. The difference in occurrence of postoperative complications will be assessed according to Dindo-Clavien grading system19 30 days after surgery.

—

Contacts

Public ContactJorinde Polderman

Afd. Anesthesiologie

j.a.polderman@amc.uva.nl+205669111 pager 57431

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)