Clinical trial NCT05641792: Continuous Glucose Monitoring for Emergency Laparotomy
Official title: Continuous Glucose Monitoring for Emergency Laparotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritonitis
Surgical Site Infection
Infections
Hyperglycemia
Hypoglycemia
Keywords: continuous glucose monitoring
CGM
Dexcom G6
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: CLUE trial aims to determine the feasibility and predictive value for surgical site infection (SSI) of continuous glucose monitoring (CGM) in emergency laparotomy patients with diffuse peritonitis.

Detailed description: Hyperglycaemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. Therefore, the investigators predict that number of hyperglycaemia episodes could be a predictor of SSI.

Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control, yet it has not been applied in an emergency surgery setting. Intraoperative glycemia monitoring would allow to determine the effect of specific interventions during a surgical procedure that may provoke hyperglycaemia.

CLUE is a single-centre prospective observational study held in an academic tertiary medical centre in Poland. Adult patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery, with class ≥ III wounds according to Centers for Disease Control and Prevention (CDC) classification, will be eligible for the CLUE trial. Patients who will be unable or will refuse to express informed consent will be excluded. Patients will be co-enrolled in PRISTINE randomized health services study that aims to compare the effectiveness of negative pressure wound therapy (NPWT) and primary closure (PC) in surgical site infection prevention.

On admission day, patients will have a Dexcom G6 system placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Patients will be randomized to NPWT or PC according to PRISTINE protocol. Glycemia will be continuously monitored for 10 days.

Eligibility criteria: Inclusion Criteria:

* emergency laparotomy for peritonitis
* written informed consent

Exclusion Criteria:

- open abdomen treatment

Primary outcomes:
measure: feasibility of CGM system
timeFrame: 10 days
Secondary outcomes:
measure: intra- and post-operative glycemia
timeFrame: 10 days
measure: postoperative morbidity
timeFrame: 30 days
measure: SSI rate
timeFrame: 30 days
measure: effective wound closure
timeFrame: 30 days
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: UCC Division of Oncological, Transplant and General Surgery
state: Pomerania
Study officials:
affiliation: MUG Division of General Surgery
name: Piotr Spychalski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Gdansk (MUG)
name: Katarzyna Polomska
role: PRINCIPAL_INVESTIGATOR
affiliation: MUG Division of General Surgery
name: Jaroslaw Kobiela, Prof.
role: PRINCIPAL_INVESTIGATOR
References: