Continuous Glucose Monitoring for Emergency Laparotomy

Hyperglycemia Clinical Trial

— CLUE  

Official title:

Continuous Glucose Monitoring for Emergency Laparotomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05641792
• Other study ID #: 420/2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2023
• Source: Medical University of Gdansk
• Contact: Katarzyna M Polomska
• Phone: +48794037928
• Email: k.polomska[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• emergency laparotomy for peritonitis

• written informed consent

Exclusion Criteria:

• open abdomen treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Hyperglycemia
• Hypoglycemia
• Infections
• Peritonitis
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• CGM (Dexcom G6)
Dexcom G6 system consists of a transmitter and sensor that measure interstitial glycaemia every 5 minutes. Measurements are transmitted via Bluetooth to a compatible device, that uploads the data on a virtual drive. This allows for remote real-time glycaemia monitoring on another device.

Locations

Country	Name	City	State
Poland	UCC Division of Oncological, Transplant and General Surgery	Gdansk	Pomerania

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of CGM system	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.	10 days
Secondary	intra- and post-operative glycemia	number of hyperglycemia episodes	10 days
Secondary	postoperative morbidity	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)	30 days
Secondary	SSI rate	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: Pain or tenderness; Localized swelling; Redness; 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.	30 days
Secondary	effective wound closure	definitive wound closure, not followed by wound dehiscence	30 days