Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Glucose 30% Intravenous Solution
DrugMeasurement 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Glucose administrationExperimental treatment 1 intervention
Trial outcomes
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
Time frame
on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burnSecondary outcomes
1
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).
Time frame
on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn2
Study of correlations between IDVG and body surface area (BSA)
Body surface area assessed on admission according to Wallace method
Time frame
at hospital admission3
Study of correlations between IDVG and water intake and input/output balance
Water intake and input/output balance (water intake minus diuresis)
Time frame
on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn4
Study of correlations between IDVG at H24 to H48 and mortality
In-hospital mortality
Time frame
at Hours 24 and 48 post-burnSponsors and contacts
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Source ClinicalTrials.gov