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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Description of the mean values of the initial volume of glucose distribution (IDVG) [Срок оценки: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn]

Вторичные конечные точки (4)

• Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW). [Срок оценки: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn]
• Study of correlations between IDVG and body surface area (BSA) [Срок оценки: at hospital admission]
• Study of correlations between IDVG and water intake and input/output balance [Срок оценки: 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 [Срок оценки: at Hours 24 and 48 post-burn]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHR Metz-Thionville/Hopital de Mercy — Metz

Идентификаторы

NCT: NCT06469970 · 2023-03-CHRMT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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