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NCT Number: NCT06469970

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location status: Recruiting

Location contact

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Boris GLAVNIK, MD

SUB_INVESTIGATOR

Mellati NOUCHAN, MD

SUB_INVESTIGATOR

Serge LE TACON, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose 30% Intravenous Solution

Drug

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.

Primary outcomes

  1. Description of the mean values of the initial volume of glucose distribution (IDVG)

    Time frame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn

    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

Secondary outcomes

  1. Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW).

    Time frame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn

    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).

  2. Study of correlations between IDVG and body surface area (BSA)

    Time frame: at hospital admission

    Body surface area assessed on admission according to Wallace method

  3. Study of correlations between IDVG and water intake and input/output balance

    Time frame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn

    Water intake and input/output balance (water intake minus diuresis)

  4. Study of correlations between IDVG at H24 to H48 and mortality

    Time frame: at Hours 24 and 48 post-burn

    In-hospital mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: INDICIA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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