Understanding glucose distribution in severely burned adults
INDICIA: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
This study is testing how glucose levels change in severely burned adults during their first four days of treatment to help doctors manage their fluids better and improve recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Metz-Thionville Academic / other |
| Locations | 1 site (Metz) |
| Trial ID | NCT06469970 on ClinicalTrials.gov |
What this trial studies
This prospective, observational, phase II cohort study aims to explore how the initial volume of glucose distribution changes during the first four days of treatment for severely burned patients. It focuses on the challenges of fluid resuscitation in burn victims, who often experience hypovolaemic shock and capillary leak syndrome. By administering a 30% intravenous glucose solution, the study seeks to quantify extracellular fluid volume as a potential marker for fluid overload, which is critical for optimizing patient management and improving outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with burns covering at least 30% of their body surface area, treated within 8 hours post-injury at the specified burn center.
Not a fit: Patients with diabetes requiring insulin or those with contraindications to glucose administration will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance fluid management strategies for severely burned patients, potentially reducing complications and mortality.
How similar studies have performed: While the approach of using glucose to assess fluid distribution is innovative, similar studies have not been widely reported, indicating this may be a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Metz
- CHR Metz-Thionville/Hopital de Mercy — Metz, France (Recruiting)
Study contacts
- Principal investigator: Serge LE TACON, MD — CHR Metz Thionville Hopital de Mercy
- Study coordinator: Arpiné EL NAR, PhD
- Email: projet-recherche-clinique@chr-metz-thionville.fr
- Phone: 0033387557766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.