Continuous Glucose Monitoring for Emergency Laparotomy

Not Applicable

Not yet recruiting

• Conditions: Hyperglycemia; Infections; Peritonitis; Surgical Site Infection; Hypoglycemia
• Interventions: Device: CGM (Dexcom G6)

• Registration Number: NCT05641792
• Lead Sponsor: Medical University of Gdansk

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02
• Study Start: 2023-03-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• emergency laparotomy for peritonitis
• written informed consent

Exclusion Criteria

• open abdomen treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM pre-, intra- and postoperatively	CGM (Dexcom G6)	Patients will have a Dexcom G6 system placed on admission on outer part of the arm, glycaemia will be monitored for 10 consecutive days

Primary Outcome Measures

Name	Time	Method
feasibility of CGM system	10 days	measured as the drop-out rate caused by non-adherence of both patients and medical staff due to system detaching, problems with the receiving device (low battery. distance beyond Bluetooth communication range) etc.

Secondary Outcome Measures

Name	Time	Method
intra- and post-operative glycemia	10 days	number of hyperglycemia episodes
postoperative morbidity	30 days	all types of postoperative complications and their severity according to Clavien-Dindo scale (grade I to V; grade I represents any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention and grade 5 represents patient's death)
effective wound closure	30 days	definitive wound closure, not followed by wound dehiscence
SSI rate	30 days	Surgical Site Infection according to Centre for Disease Control criteria: Infection occurring within the first 30 post-operative days with at least one of the following: * Purulent drainage from the incision; * Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision; * Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection: 1. Pain or tenderness; 2. Localized swelling; 3. Redness; 4. Heat; * Diagnosis of SSI by the surgeon or attending physician; Due to the inability to implement CDC for wounds treated with NPWT, the investigators have included additional SSI criteria: the absolute necessity to prolong NPWT after 3rd day postop, an anergic wound morphology or slough.

Trial Locations

Locations (1)

UCC Division of Oncological, Transplant and General Surgery; 🇵🇱 Gdańsk, Pomerania, Poland