Evaluation of the effect of peri-operative continuation of oral metformin therapy on the incidence of perioperative hyperglycemia compared to standard preoperative cessation of oral metformin therapy 24h before surgery.
Surgical procedures cause metabolic stress and can impair glucose control especially in patients with diabetes mellitus, which often results in peri-operative hyperglycemia. Peri-operative hyperglycemia is associated with impaired wound healing, secondary wound infections, endothelial dysfunction, sepsis, prolonged hospital stay and higher mortality. Metformin is still the first line treatment in patients with type 2 diabetes mellitus. Historically it has been stopped before surgery due to fear of hypoglycemia and metformin induced lactic acidosis. However recent studies have suggested that perioperative continuation of metformin might be safe and patients could benefit from more stable preoperative blood sugar levels. Prospective studies evaluating the benefit of continuing oral metformin therapy in the perioperative period are rare. The investigators plan to conduct a prospective, randomized-controlled, unblinded clinical trial where patients with type II diabetes mellitus and oral metformin therapy undergoing non-cardiac surgery will be randomized in either an interventional group or a control group. In the interventional group patients will be instructed to continue their regular metformin dose even on the day of surgery, in contrast to the control group, where the patients will be instructed to stop taking metformin 24h prior to surgery. All other oral anti-diabetic drugs will be paused according to the local anesthesia guidelines. The investigators plan to evaluate whether or not continuation of metformin can reduce the incidence of perioperative hyperglycemia and whether or not it is associated with elevation of blood lactate levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
Perioperative continuation of oral metformin therapy according to the patient's normal dosage and dosage intervals
Incidence of Perioperative Hyperglycemia
blood glucose \>180mg/dl (10mmol/l) and/or necessity of additive administration of insulin s.c. during the time frame
Time frame: 24 hours pre-op until 24 hours post-op
Perioperative blood glucose control
mean plasma glucose at 4 defined dates: 24h pre-op, intra-op, 2hours post-op and 24h post-op
Time frame: 24 hours pre-op until 24 hours post-op
Incidence hypoglycemia
blood sugar levels \< 70mg/dl (3.9mmol/l)
Time frame: 24 hours pre-op until 24 hours post-op
Perioperative lactate levels
mediane lactate levels at 4 defined dates: 24h pre-op, intra-op, 2 hours post-op and 24h post-op
Time frame: 24 hours pre-op until 24 hours post-op
Incidence of hyperlactatemia
blood lactate values \>4mmol/L at least at one of 4 measurement dates: 24h pre-op, intra-op, 2 hours post-op, 24 hours post-op
Time frame: 24 hours pre-op until 24 hours post-op
Perioperative renal function
median serum-creatinine value at 24h pre-op and 24h post-op
Time frame: 24 hours pre-op until 24 hours post-op
Hospitalization Duration
median time period from day of surgery until discharge from hospital
Time frame: up to 4 weeks
Mortality
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In-Hospital mortality
Time frame: up to 4 weeks