RecruitingPhase 2NCT06469970

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

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


Sponsor

Centre Hospitalier Régional Metz-Thionville

Enrollment

15 participants

Start Date

Nov 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria10

  • 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

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Interventions

DRUGGlucose 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 volume (ITBV) and extra-vascular lung water (EVLW) are measured using the PiCCO device as part of the usual management of burn patients.


Locations(1)

CHR Metz-Thionville/Hopital de Mercy

Metz, France

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NCT06469970


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