BurnsPhase 2INDICIANCT06469970
Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
A Phase 2 study testing Glucose 30% Intravenous Solution in people with Burns and Intensive Care, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Intensive Care, Emergencies
- What is being tested?
- Glucose 30% Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2024to 28 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville/Hopital de Mercy
Metz, 57085
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Serge LE TACON, MD
About this study
Official title: INDICIA: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
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.
Read the detailed description
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.
- Conditions
- Burns, Intensive Care, Emergencies
- Being tested
- Glucose 30% Intravenous Solution
- Medical subject headings
- Burns, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose 30% Intravenous SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucose administration | Experimental | Not described Receives: Drug: Glucose 30% Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the mean values of the initial volume of glucose distribution (IDVG)
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
Measured: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
Secondary outcomes (4)
Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW).
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).
Measured: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
Study of correlations between IDVG and body surface area (BSA)
Body surface area assessed on admission according to Wallace method
Measured: at hospital admission
Study of correlations between IDVG and water intake and input/output balance
Water intake and input/output balance (water intake minus diuresis)
Measured: 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
In-hospital mortality
Measured: at Hours 24 and 48 post-burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start28 Nov 2024
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, observational, single-centre phase II (exploratory) cohort study aiming to describe changes in initial distribution volume of glucose (IDVG) during the first 4 days of care for patients with severe burns. Patients will be included on admission to the Burn Treatment Centre and IDVG will be measured on admission, then every 8 hours for the first 24 hours of the stay, then every 24 hours until the fourth day. The rest of the evaluation criteria correspond to standard practice in the management of severely burned patients according to the department's procedure.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge LE TACON, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469970
- Sponsor's protocol ID
- 2023-03-CHRMT
- Acronym
- INDICIA
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INDICIA: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
- ClinicalTrials.gov ID
- NCT06469970
- Acronym / sponsor ID
- INDICIA / 2023-03-CHRMT
- Conditions
- Burns, Intensive Care, Emergencies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, observational, single-centre phase II (exploratory) cohort study aiming to describe changes in initial distribution volume of glucose (IDVG) during the first 4 days of care for patients with severe burns. Patients will be included on admission to the Burn Treatment Centre and IDVG will be measured on admission, then every 8 hours for the first 24 hours of the stay, then every 24 hours until the fourth day. The rest of the evaluation criteria correspond to standard practice in the management of severely burned patients according to the department's procedure.
| Arm | Type | Receives |
|---|---|---|
| Glucose administration | Experimental | Drug: Glucose 30% Intravenous Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years of age
- Patients hospitalized with burns of at least 30% of body surface area
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose 30% Intravenous SolutionMeasurement 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. | Drug | Glucose administration |
Primary outcome
Description of the mean values of the initial volume of glucose distribution (IDVG)
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
4 secondary outcomes
Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW).
Time frame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
Study of correlations between IDVG and body surface area (BSA)
Time frame: at hospital admission
Study of correlations between IDVG and water intake and input/output balance
Time frame: 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
Time frame: at Hours 24 and 48 post-burn
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serge LE TACON, MD principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucose 30% Intravenous Solution in people with Burns and Intensive Care, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the mean values of the initial volume of glucose distribution (IDVG) (time frame: on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.