Clinical trial NCT06469970: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
Official title: INDICIA: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Burns
Intensive Care
Emergencies
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, observational, single-centre phase II (exploratory) cohort study aiming to describe changes in initial distribution volume of glucose (IDVG) during the first 4 days of care for patients with severe burns. Patients will be included on admission to the Burn Treatment Centre and IDVG will be measured on admission, then every 8 hours for the first 24 hours of the stay, then every 24 hours until the fourth day. The rest of the evaluation criteria correspond to standard practice in the management of severely burned patients according to the department's procedure.
Primary purpose: TREATMENT

Brief 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.

Detailed description: In the early phase, severe burns induce a state of hypovolaemic shock linked to inflammation and a capillary leak syndrome, responsible for the formation of a voluminous third sector. Initial resuscitation of burn patients is based on an assessment of filling requirements using the Parkland formula, which takes into account the patient's weight and the percentage of burned skin surface. This haemodynamic resuscitation oscillates between a risk of underfilling, responsible for hypovolaemia with low cardiac output and leading to excess mortality, and a state of hydric hyperinflation responsible for numerous complications such as respiratory distress, cardiac failure, abdominal compartment syndrome, and even excess mortality. The necessary adaptation of vascular filling rates is usually achieved by monitoring clinical parameters such as diuresis, or biological parameters such as arterial lactate or haematocrit. More advanced haemodynamic monitoring may be applied in addition, but the targets chosen and their numerical objectives remain to be validated. Due to the burn-induced capillary leak syndrome, quantification of extracellular (intra- and extravascular) fluid volume (ECFV) could be a relevant marker of fluid overload status in severely burned patients. ECFV can be estimated using intravenous glucose. Glucose is distributed throughout the extracellular fluid compartment within a few minutes, and defines an initial volume of glucose distribution (IDVG) proportional to the ECFV. This measurement has been validated in healthy individuals and in various pathological conditions. In intensive care patients, the values are between 3.1 and 4.8 L/m2.

To the best of our knowledge, no study has assessed variations in ECV measured by the LVDI in severely burned patients in the early phase of intensive care. Understanding these variations could make a definite contribution to the adaptation of perfused fluid volumes.

Eligibility 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW).
timeFrame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
measure: Study of correlations between IDVG and body surface area (BSA)
timeFrame: at hospital admission
measure: Study of correlations between IDVG and water intake and input/output balance
timeFrame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
measure: Study of correlations between IDVG at H24 to H48 and mortality
timeFrame: at Hours 24 and 48 post-burn
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Serge LE TACON, MD
role: PRINCIPAL_INVESTIGATOR
References: