Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults

Last updated: May 12, 2025
Sponsor: Centre Hospitalier Régional Metz-Thionville
Overall Status: Active - Recruiting

Phase

2

Condition

Skin Wounds

Hyponatremia

Treatment

Glucose 30% Intravenous Solution

Clinical Study ID

NCT06469970
2023-03-CHRMT
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orrelatives if the patient is unable to sign/express consent) or emergency inclusionif the patient is unable to express consent and neither the trusted support personnor any member of the family or relatives is present at the time of inclusion.

Exclusion

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 ReplacementTherapy)

  • patient without a central venous line or arterial catheter

  • Patient moribund or immediately subject to therapeutic limitation

  • Impossibility of trans-pulmonary thermodilution monitoring (vascular accessdifficulties)

  • Pregnant, parturient or breast-feeding women

  • Patient under guardianship, curatorship or safeguard of justice

  • Cognitive impairment or language barrier

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Glucose 30% Intravenous Solution
Phase: 2
Study Start date:
November 28, 2024
Estimated Completion Date:
March 28, 2027

Study 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.

Connect with a study center

  • CHR Metz-Thionville/Hopital de Mercy

    Metz, 57085
    France

    Active - Recruiting

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