An interventional study of CGM (Dexcom G6) in Peritonitis, Surgical Site Infection and Infections, sponsored by Medical University of Gdansk. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Supportive care
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.
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 50 is below the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Medical University of Gdansk is the lead sponsor of 133 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
Time frame: 10 days
intra- and post-operative glycemia
number of hyperglycemia episodes
Time frame: 10 days
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)
Time frame: 30 days
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: 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.
Time frame: 30 days
effective wound closure
definitive wound closure, not followed by wound dehiscence
Time frame: 30 days
Start is estimated for Mar 2023; primary completion for Dec 2024, 20 months later.
Of 23 interventional studies with no phase under Peritonitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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