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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burns; Emergencies; Intensive Care
• Intervention / Treatment: Drug: Glucose 30% Intravenous Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57085
    • Recruiting
    • CHR Metz-Thionville/Hopital de Mercy
    • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr
    • Principal Investigator: Serge LE TACON, MD
    • Sub-Investigator: Mellati NOUCHAN, MD
    • Sub-Investigator: Boris GLAVNIK, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Glucose administration

Drug: Glucose 30% Intravenous Solution; Measurement of IDVG on admission, at 4 hours (H+4), and at 8, 16, 24, 48, 72 and 96 hours (H+8, H+16, H+24, H+48, H+72 and H+96) post-burn. The principle of this measurement consists of taking a reference blood glucose level measured on an arterial blood sample (arterial catheter) using a blood glucose meter. A bolus of 5g of glucose is injected into a central venous line over 30 seconds. A second blood glucose level is measured 3 minutes after the end of the injection. The intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW) are measured using the PiCCO device as part of the usual management of burn patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the mean values of the initial volume of glucose distribution (IDVG)	The IDVG is calculated according to the method described by Hitota et al. A reference blood glucose level is measured on an arterial blood sample (arterial catheter) by a blood glucose meter. A bolus of 5 g of glucose is injected into a central venous line over 30 seconds. A second blood glucose level is measured 3 minutes after the end of the injection. The difference between the two blood glucose levels is recorded as d[glu] in mg/dl. IDVG = 24.4 x e(-0.0298 * d[glu]) + 2.7 in liters	on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW).	ITBV (intra-thoracic blood volume) and EVLW (extra-vascular lung water) measured at the same time as IDVG, using the PiCCO device and trans-lung dilution of a thermal indicator (cold saline).	on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
Study of correlations between IDVG and body surface area (BSA)	Body surface area assessed on admission according to Wallace method	at hospital admission
Study of correlations between IDVG and water intake and input/output balance	Water intake and input/output balance (water intake minus diuresis)	on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
Study of correlations between IDVG at H24 to H48 and mortality	In-hospital mortality	at Hours 24 and 48 post-burn

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Serge LE TACON, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Burns; Carbohydrates; Sugars; Hexoses; Monosaccharides; Glucose
• Other Study ID Numbers: 2023-03-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No