Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
15
Countries
1
Sites
1
Severe burns
Description of the mean values of the initial volume of glucose distribution (IDVG) during the first four days of management of a severely burned patient.
Key facts
- Sponsor
- Centre Hospital Region Metz Thionville
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 27 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Description of the mean values of the initial volume of glucose distribution (IDVG) during the first four days of management of a severely burned patient.
Secondary objectives 5
- Correlation between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW).
- Correlation between IDVG and body surface area (BSA)
- Correlation between IDVG and water intake and input/output balance
- Correlation between IDVG at H24 to H48 and mortality
- Description of glycemic changes before and after injection of the glucose bolus for IDVG measurement.
Conditions and MedDRA coding
Severe burns
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients over 18 years of age
- 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
- 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 criteria 10
- Diabetic patients on insulin
- Patient with a CONTRAINDICATION to GLUCOSE 30% PROAMP, solution for injection
- Patients with pre-hospital cardiac arrest
- Patient with extra corporeal circulation : Extra Corporeal Membranous Oxygenation (ECMO) or Extra Corporeal Life Support (ECLS) or CRRT (Continuous Renal Replacement Therapy)
- Patient without 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 5
- 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).
- Body surface area assessed on admission (Wallace method)
- Water intake and input/output balance (water intake minus diuresis)
- In-hospital mortality
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
GLUCOSE 30 % PROAMP, solution injectable
PRD584341 · Product
- Active substance
- Glucose
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 300 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 300 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BA03 — CARBOHYDRATES
- Marketing authorisation
- 34009 371 747 7 0
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospital Region Metz Thionville
- Sponsor organisation
- Centre Hospital Region Metz Thionville
- Address
- 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Ars Laquenexy Cs 45001 Ars Laquenexy Ars Laquenexy
- City
- Metz Cedex 03
- Postcode
- 57085
- Country
- France
Scientific contact point
- Organisation
- Centre Hospital Region Metz Thionville
- Contact name
- LE TACON Serge
Public contact point
- Organisation
- Centre Hospital Region Metz Thionville
- Contact name
- LE TACON Serge
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospital Region Metz Thionville
Centre de Traitement des Grands-Brûlés, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-11-27 | 2024-11-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | France | Acceptable 2024-09-02
|
2024-09-03 |