Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults (NCT06469970) | Clinical Trial Compass
RecruitingPhase 2
Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
France15 participantsStarted 2024-11-28
Plain-language summary
This is a prospective, observational, monocentric, phase II (exploratory) cohort study aiming to describe the evolutionary profile of the initial volume of glucose distribution (IDVG) during the first four days of management of severely burned patient.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients over 18 years of age
* Patients hospitalized with burns of at least 30% of body surface area
* By a thermal mechanism
* At the CHR Metz-Thionville burn center
* managed within the 8 hours post-burn
* Patient affiliated to a social security scheme
* Written consent obtained from the patient (or from the trusted person, family or relatives if the patient is unable to sign/express consent) or emergency inclusion if the patient is unable to express consent and neither the trusted support person nor any member of the family or relatives is present at the time of inclusion.
Exclusion Criteria:
* Diabetic patients on insulin
* Patient with a CONTRAINDICATION to GLUCOSE 30% PROAMP, solution for injection
* Patients with pre-hospital cardiac arrest
* extra corporeal circulation patient: Extra Corporeal Membranous Oxygenation (ECMO) or Extra Corporeal Life Support (ECLS) or CRRT (Continuous Renal Replacement Therapy)
* patient without a central venous line or arterial catheter
* Patient moribund or immediately subject to therapeutic limitation
* Impossibility of trans-pulmonary thermodilution monitoring (vascular access difficulties)
* Pregnant, parturient or breast-feeding women
* Patient under guardianship, curatorship or safeguard of justice
* Cognitive impairment or language barrier
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Description of the mean values of the initial volume of glucose distribution (IDVG)
Timeframe: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn