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

NCT06469970 | Recruiting Phase 2

• 1 other identifier: 2023-03-CHRMT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Intensive Care; Emergencies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

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

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

  at hospital admission

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

  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

  at Hours 24 and 48 post-burn

Study Arms (1)

Glucose administration

EXPERIMENTAL

Drug: Glucose 30% Intravenous Solution

Interventions

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.

Glucose administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Burns; Emergencies

Interventions

Glucose

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Serge LE TACON, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: November 28, 2024
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)