Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults (INDICIA)

Centre Hospitalier Régional Metz-Thionville

Status and phase

Enrolling

Phase 2

Conditions

Emergencies

Burns

Intensive Care

Treatments

Drug: Glucose 30% Intravenous Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT06469970

2023-03-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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