GLUCOSE for Severe burns

Inclusion criteria

• {"criterion_text":"- Patients over 18 years of age"}
• {"criterion_text":"- Patients hospitalized with burns of at least 30% of body surface area o By a thermal mechanism o At the CHR Metz-Thionville burn center o managed within the 8 hours post-burn"}
• {"criterion_text":"- Patient affiliated to a social security scheme"}
• {"criterion_text":"- 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 criteria

• {"criterion_text":"- Diabetic patients on insulin"}
• {"criterion_text":"- Cognitive impairment or language barrier"}
• {"criterion_text":"- Patient with a CONTRAINDICATION to GLUCOSE 30% PROAMP, solution for injection"}
• {"criterion_text":"- Patients with pre-hospital cardiac arrest"}
• {"criterion_text":"- Patient with extra corporeal circulation : Extra Corporeal Membranous Oxygenation (ECMO) or Extra Corporeal Life Support (ECLS) or CRRT (Continuous Renal Replacement Therapy)"}
• {"criterion_text":"- Patient without central venous line or arterial catheter"}
• {"criterion_text":"- Patient moribund or immediately subject to therapeutic limitation"}
• {"criterion_text":"- Impossibility of trans-pulmonary thermodilution monitoring (vascular access difficulties)"}
• {"criterion_text":"- Pregnant, parturient or breast-feeding women"}
• {"criterion_text":"- Patient under guardianship, curatorship or safeguard of justice"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"IDVG calculated per Hitota et al.: measure arterial reference blood glucose, inject 5 g glucose bolus via central venous line over 30 seconds, measure second arterial glucose 3 minutes after injection, record difference d[glu] (mg/dl); compute IDVG = 24.4 x e(-0.0298 * d[glu]) + 2.7 (liters)."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured concurrently with IDVG using the PiCCO device via trans-pulmonary thermodilution (thermal indicator: cold saline)."}
• {"endpoint_text":"- Body surface area assessed on admission (Wallace method)","definition_or_measurement_approach":"Assessment of body surface area on admission using the Wallace method."}
• {"endpoint_text":"- Water intake and input/output balance (water intake minus diuresis)","definition_or_measurement_approach":"Calculation of water balance as water intake minus diuresis (input/output recording)."}
• {"endpoint_text":"- In-hospital mortality","definition_or_measurement_approach":"Recording of mortality occurring during hospital stay."}
• {"endpoint_text":"- Arterial blood glucose levels will be measured in g/L just before and 3 minutes after the end of the glucose bolus injection, using a glucometer.","definition_or_measurement_approach":"Arterial blood glucose measured in g/L with a glucometer immediately before and 3 minutes after glucose bolus injection."}

France

Earliest CTIS Part Ii Submission Date

09-07-2024

Latest Decision Or Authorization Date

03-09-2024

Processing Time Days

56

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Centre Hospital Region Metz Thionville

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France