CHR Metz-Thionville/Hopital de Mercy
Metz, 57085, France
Location status: Recruiting
Location contact
Arpiné EL NAR, PhD
CONTACT
Boris GLAVNIK, MD
SUB_INVESTIGATOR
Mellati NOUCHAN, MD
SUB_INVESTIGATOR
Serge LE TACON, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06469970
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Metz, 57085, France
Location status: Recruiting
Arpiné EL NAR, PhD
CONTACT
Boris GLAVNIK, MD
SUB_INVESTIGATOR
Mellati NOUCHAN, MD
SUB_INVESTIGATOR
Serge LE TACON, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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).
Time frame: at hospital admission
Body surface area assessed on admission according to Wallace method
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)
Time frame: at Hours 24 and 48 post-burn
In-hospital mortality
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Régional Metz-Thionville
Other
INDICIA: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
Acronym: INDICIA
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