Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark
Copenhagen, 2400, Denmark
NCT Number: NCT07349199
Patients who undergo major surgery face a 15-30% risk of serious adverse events, including a 1-5% mortality risk in the first month after surgery. For patients with diabetes, the risk is even greater, and it is often aggravated by complications associated with hyper- and hypoglycaemia. Complications, such as wound infections, cardiovascular, and neurological events, not only affect patients negatively, but it challenges health care systems due to prolonged length of stays and increased need of care post-discharge.
Several factors make it particularly difficult to establish glycaemic control and stable blood sugar in patients with diabetes. Patients' usual glucose-lowering medications are often paused, and fasting is required at least six hours prior to the operation. Surgery induces a post-surgical stress response that may include both stress-hyperglycaemia and reduced gastrointestinal function. Furthermore, a patient's usual symptoms of hyper- and hypoglycaemia may be altered due to the anaesthetics.
The existing guidelines on perioperative diabetic care include recommendations on treatment and glucose monitoring from the preoperative fasting period to the postoperative phase where oral intake of food and drinks can be resumed. Intravenous glucose-insulin infusions are used during preoperative fasting, intraoperatively and postoperatively until patients can resume oral intake of food and drinks. After this, subcutaneous insulin administrations following the sliding scale insulin regimen are administered to the patients to treat hyperglycaemia and supplemental glucose (perorally or intravenously) in case of hypoglycaemia. The blood sugar levels are monitored via point-of-care (POC) blood glucose tests every hour during glucose-insulin infusions and four to six times daily in the postoperative period.
In spite of these guidelines, prospective studies have shown that blood glucose levels are outside the normal range in 40-60% of the time following major surgery, and usually due to hyperglycaemia.
In this registry study, we investigated how guidelines for perioperative diabetes care were implemented in Danish hospitals from 2017-2023. The primary hypothesis was that, in the 20% of cases with detected hyperglycaemia, insufficient insulin was provided thus not following exiting guidelines.
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Notify Me18 year and older
All sexes
Observational
Copenhagen, 2400, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.
The proportion of hyperglycaemic events in which the recommended insulin dose, according to the interregional guideline, is administered. Correct dosing is defined as administration of the guideline-recommended dose of rapid-acting insulin (international units [IU], whole numbers) from 15 min. prior to 1 hour after detection of hyperglycaemia.
Time frame: Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.
The proportion of hyperglycaemic events in which the recommended insulin dose, according to the interregional guideline, is NOT administered. Correct dosing is defined as administration of the guideline-recommended dose of rapid-acting insulin (international units [IU], whole numbers) from 15 min. prior to 1 hour after detection of hyperglycaemia.
Time frame: Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.
The proportion of hyperglycaemic events in which a lower insulin dose than the recommended insulin dose, according to the interregional guideline, is administered. Correct dosing is defined as administration of the guideline-recommended dose of rapid-acting insulin (international units [IU], whole numbers) from 15 min. prior to 1 hour after detection of hyperglycaemia.
Time frame: Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge
Exploratory clinical outcome assessing non-adherent hyperglycaemia managment as an exposure of the outcome (postopertaive length of hospital stay, assessed in days)
Time frame: Day 1 (defined as discharge from the post-anaesthesia care unit) until Day 30
Exploratory clinical outcome assessing non-adherent hyperglycaemia managment as an exposure of the outcome (admission to an intensive care unit after surgery)
Time frame: Day 1 (defined as discharge from the post-anaesthesia care unit) until Day 30
Exploratory clinical outcome assessing non-adherent hyperglycaemia managment as an exposure of the outcome (all-cause mortality)
University Hospital Bispebjerg and Frederiksberg
Other
Adherence to Clinical Guidelines on Perioperative Diabetes Care in Hospitalised Patients. A Retrospective Cohort Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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