Continuous Glucose Monitoring for Emergency Laparotomy

NCT05641792 | Unknown

• 1 other identifier: 420/2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritonitis; Surgical Site Infection; Infections; Hyperglycemia; Hypoglycemia

Keywords

continuous glucose monitoring; CGM; Dexcom G6

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• intra- and post-operative glycemia

  10 days

• postoperative morbidity

  30 days

• SSI rate

  30 days

• effective wound closure

  30 days

Study Arms (1)

CGM pre-, intra- and postoperatively

EXPERIMENTAL

Patients will have a Dexcom G6 system placed on admission on outer part of the arm, glycaemia will be monitored for 10 consecutive days

Device: CGM (Dexcom G6)

Interventions

CGM (Dexcom G6) DEVICE

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.

Also known as: continuous glucose monitoring, CGM, Dexcom G6

CGM pre-, intra- and postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• emergency laparotomy for peritonitis
• written informed consent

You may not qualify if:

• \- open abdomen treatment

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

UCC Division of Oncological, Transplant and General Surgery

Gdansk, Pomeranian Voivodeship, 80952, Poland

Location

MeSH Terms

Conditions

Peritonitis; Surgical Wound Infection; Infections; Hyperglycemia; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Peritoneal Diseases; Digestive System Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Piotr Spychalski, MD, PhD

  MUG Division of General Surgery

  PRINCIPAL INVESTIGATOR

• Katarzyna Polomska

  Medical University of Gdansk (MUG)

  PRINCIPAL INVESTIGATOR

• Jaroslaw Kobiela, Prof.

  MUG Division of General Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna M Polomska

CONTACT

+48794037928; k.polomska@gumed.edu.pl

Piotr Spychalski, MD, PhD

CONTACT

+48667843555; piotr.spychalski@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: March 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

PL (1)