In this study we want to prospectively investigate in a large ambulatory surgical cohort in which patients glucose levels increase during surgery and whether this is related to postoperative complications.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints will be mean glucose change during ambulant surgery as
compared to presurgery fasting glucose, proportion patients reaching a glucose
value of * 7.8 mmol/l during admission, association between patients with
glucose of * 7.8 mmol and seeking any medical help within the first 30 days
after discharge.
Secondary outcome
Secondary endpoints will include mean change in glucose during surgery analyzed
with specific tests; predictive regression model for perioperative
hyperglycaemia; and the association between glucose change and any complication
within the first 60 days after discharge.
Background summary
There is a considerable proportion of surgical patients that will develop
hyperglycaemia during hospital admission, which will resolve spontaneously
after hospital discharge, also called stress hyperglycaemia. When considering
intra-operative hyperglycaemia, evidence is mounting that perioperative
hyperglycaemia is related to postoperative complications after major surgery.
Recently, it has been shown that glucose variability in combination with
hyperglycaemia further contributes to this risk, which was in line with a
previous study in the ICU, where increased glucose variability was associated
with ICU mortality.
Currently, there are no trials that have evaluated the application and efficacy
of perioperative glucose control in a non-ICU setting to target hyperglycaemia.
Evidence with regard to glucose control in patients undergoing ambulant surgery
is scarce, whereas they constitute the largest surgical population that might
be at risk for in-hospital hyperglycaemia.
Study objective
In this study we want to prospectively investigate in a large ambulatory
surgical cohort in which patients glucose levels increase during surgery and
whether this is related to postoperative complications.
Study design
multicentre prospective observatiobnal cohort study
Study burden and risks
The only additional risk involved with this study is an infection at the
fingerstick injection site. This risk is small en easily treated. Potential
benefits include finding undiagnosed diabetes mellitus. A patient has the right
to withdraw from the study at any time. Reasons for dropouts, if available,
will be documented.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Willing and able to give written informed consent
* Scheduled for ambulant surgery
* Age 18-85 years
Exclusion criteria
* Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37311.018.11 |