In this study we want to investigate whether hyperglycaemia and blood glucose variability independently predicts postoperative complications in patients undergoing major abdominal surgery.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main endpoint is the relation between postoperative complications and
hyperglycaemia and glucose variability.
Secondary outcome
Secondary endpoint is the difference in glucose increase and variability
between different surgical procedures and treating specialties.
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
or glucose variability.
Randomized controlled trials are needed in this area, but first we have to
identify which patient groups are at risk for perioperative hyperglycemia and
glucose variability, as we know that not all patient groups show the
association between hyperglycaemia and postoperative complications
Study objective
In this study we want to investigate whether hyperglycaemia and blood glucose
variability independently predicts postoperative complications in patients
undergoing major abdominal surgery.
Study design
This is a single center prospective observational cohort study.
Study burden and risks
There are no risks associated with this study. A potential benefit may be the
detection of undiagnosed diabetes mellitus. In general, after completion of
this study the importance of hyperglycaemia and glucose variability during
major abdominal surgery is investigated. This is a final and necessary step
before a randomized controlled intervention trial treating intraoperative
hyperglycaemia is considered.
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 to undergo major abdominal surgery
- Age 18-85 years
Exclusion criteria
- Early termination of the procedure
- Conditions necessitating prolonged stay (beyond the first postoperative day) at the recovery room, readmission to the recovery room, or admission to an intensive or medium care unit
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 | NL37308.018.11 |