PeritonitisCLUENCT05641792
Continuous Glucose Monitoring for Emergency Laparotomy
A study testing CGM (Dexcom G6) in people with Peritonitis and Surgical Site Infection, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis, Surgical Site Infection, Infections
- What is being tested?
- CGM (Dexcom G6)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 15 Mar 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- emergency laparotomy for peritonitis
- written informed consent
Who cannot join
- open abdomen treatment
Trial locations and contacts
1 site in 1 country.
Poland1 site
UCC Division of Oncological, Transplant and General Surgery
Gdansk, Pomeranian Voivodeship, 80952
About this study
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.
Read the 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.
- Conditions
- Peritonitis, Surgical Site Infection, Infections, Hyperglycemia, Hypoglycemia
- Being tested
- CGM (Dexcom G6)
- Keywords
- continuous glucose monitoring, CGM, Dexcom G6
- Medical subject headings
- Peritonitis, Surgical Wound Infection, Infections, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM (Dexcom G6)Device
Also called continuous glucose monitoring, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CGM (Dexcom G6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (4)
intra- and post-operative glycemia
number of hyperglycemia episodes
Measured: 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)
Measured: 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:
- 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.
Measured: 30 days
effective wound closure
definitive wound closure, not followed by wound dehiscence
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start15 Mar 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Spychalski, MD, PhD, Principal investigator, MUG Division of General SurgeryKatarzyna Polomska, Principal investigator, Medical University of Gdansk (MUG)Jaroslaw Kobiela, Prof., Principal investigator, MUG Division of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641792
- Sponsor's protocol ID
- 420/2
- Acronym
- CLUE
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring for Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT05641792
- Acronym / sponsor ID
- CLUE / 420/2
- Conditions
- Peritonitis, Surgical Site Infection, Infections, Hyperglycemia, Hypoglycemia
- Keywords
- continuous glucose monitoring, CGM, Dexcom G6
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM pre-, intra- and postoperatively | Experimental | Device: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- emergency laparotomy for peritonitis
- written informed consent
Key exclusion criteria (1 listed)
- open abdomen treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM (Dexcom G6)Also: continuous glucose monitoring, CGM, Dexcom G6Dexcom 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. | Device | CGM pre-, intra- and postoperatively |
Primary outcome
feasibility of CGM system
Time frame: 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.
4 secondary outcomes
intra- and post-operative glycemia
Time frame: 10 days
postoperative morbidity
Time frame: 30 days
SSI rate
Time frame: 30 days
effective wound closure
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Spychalski, MD, PhD principal investigator
MUG Division of General Surgery
Katarzyna Polomska principal investigator
Medical University of Gdansk (MUG)
Jaroslaw Kobiela, Prof. principal investigator
MUG Division of General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM (Dexcom G6) in people with Peritonitis and Surgical Site Infection, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna M Polomska (+48794037928, k.polomska@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of CGM system (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.