The objective of the study is to investigate the glucose lowering potential and safety of continuation of Metformin during non-cardiac surgery, compared to discontinuation of Metformin 24 hours before surgery.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in postoperative glucose values 2 hours after surgery
Secondary outcome
The difference in fasting glucose values at day 1 after surgery.
The difference in lactate levels 2 hours after surgery and at day 1 after
surgery.
The difference in the amount of insulin administered during surgery.
The occurrence of mild and severe hypoglycaemia (glucose <4.0 mmol/l and <2.3
mmol/l, respectively)
The difference in length of stay (days) and postoperative complications 30 days
after surgery.
Background summary
Metformin, a widely used oral glucose lowering agent for patients with diabetes
mellitus type 2, has been associated with lactate acidosis, especially in
patients with co-morbidity - such as kidney- and heart failure. For this reason
Metformin is usually stopped before surgery. This is also recommended by
several guidelines for care of diabetic patients during the perioperative
period. However, recent (meta-)analyses demonstrated that this fear for lactate
acidosis is not supported by the available evidence. In contrast, the
discontinuation of Metformin before surgery predisposes patients to
perioperative hyperglycaemia, leading to postoperative complications.
Therefore, following the guidelines might * in this case * lead to worse
outcome of respective patients. In this randomized controlled trial we will
investigate the glucose lowering potential as well as the safety regarding
lactate acidosis of continuing Metformin during non-cardiac surgery, as
compared to discontinuation of Metformin 24 hours before surgery.
A glucose lowering effect of 1 mmol/l after continuation of Metformin would be
clinically significant and relevant, because of the possible decrease of
postoperative complications and length of hospital stay with stricter blood
glucose control.
Study objective
The objective of the study is to investigate the glucose lowering potential and
safety of continuation of Metformin during non-cardiac surgery, compared to
discontinuation of Metformin 24 hours before surgery.
Study design
National Multicenter Randomised Controlled Trial
Intervention
Stopping metformin use 24 hours preoperatively.
Study burden and risks
Prior to surgery, HbA1C, lactate and fasting glucose will be obtained. Two
hours after surgery and on day 1 postoperatively, blood glucose and lactate
will be measured in whole venous blood with blood gas analyses (Radiometer
Copenhagen). Common adverse events with Metformin treatment are related to the
gastrointestinal system, with nausea and diarrhoea reported most frequently.
However these adverse events usually occur when Metformin treatment is
initiated. As patients are already on Metformin treatment we don*t expect these
events to occur. Metformin has a low risk of developing hypoglycaemia. There
will be extensive glucose monitoring to detect any hypoglycaemia
perioperatively, and adequate therapy can then be initiated. A possible benefit
is a better glycaemic control during surgery, probably leading to a reduction
of postoperative complications.
A patient has the right to withdraw from the study at any time. Reasons for
dropouts, if available, will be documented.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent
Aged 18-80 years
Scheduled for elective non-cardiac surgery
Known diabetes mellitus type 2 for > 3 months
Using metformin > 3 months
Exclusion criteria
Insulin use
Planned day case/outpatient surgery
Planned OR-duration * 45 min
Planned ICU stay post-operatively
Existing severe liver disease or alcohol abuse
Known renal function impairment
Planned corticosteroid treatment perioperatively
Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL51964.018.15 |
| OMON | NL-OMON24837 |