BurnsCAROLENCT03271268
Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients
An observational study of Burns, run by Saint-Louis Hospital, Paris, France at 1 site in France.
Trial summary
Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2017to 6 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Severely ill burn patients admitted to a tertiary referral burn center
Who may be able to join
- Intubated mechanically-ventilated patients within the first 24 hours of admission
- And/or patients with total body surface area (TBSA) burn-injured >20 %
- And/or patients with at least 10% full-thickness burns
- And/or receiving vasopressors within the first 24 hours of admission
- And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)
Who cannot join
- Admission delay to ICU > 24 hours post burn
- Age less than 18 years
- Pregnancy
- Chronic renal impairment with a baseline eGFR < 15 ml/min
- Patients with chemical or electrical burns
- Coexisting non-burn trauma
- Patients moribund on admission or dead within 72 h from admission
- Patients with do-not-resuscitate orders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Sabri SOUSSI
Paris, Île-de-France Region, 75010
Sabri Soussi, MD, 0613064542 ext. +33, sabri.soussi@gmail.com
Matthieu Legrand, MD, PhD, 0685104235 ext. +33, matthieu.m.legrand@gmail.com
About this study
Official title: The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients
Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.
The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .
Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.
- Conditions
- Burns
- Keywords
- Vascular filling, Fluid overload, Biomarkers, Lung edema
- Medical subject headings
- Burns, Edema, Pulmonary Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung edema
Extravascular lung water (EVLW) > 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)
Measured: During the first 7 days of admission
Secondary outcomes (7)
Hypoxemia
PaO2/FiO2 ratio of <200
Measured: During the first 7 days of admission for mechanically-ventilated patients
Hypercapnia
PaCO2> 45 mmHg
Measured: During the first 7 days of admission for mechanically-ventilated patients
Corrected minute ventilation > 10L/min
Minute ventilation × partial [Paco2]/40) > 10L/min
Measured: During the first 7 days of admission for mechanically-ventilated patients
Multiple organ dysfunction syndrome (MODS)
Sequential Organ Failure Assessment score (SOFA) ≥ 8
Measured: During the first 7 days of admission
28-day mortality
Measured: 28 days
90-day mortality
Measured: 90 days
Length of stay in the ICU
Measured: until 90 days of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start6 Aug 2017
- Primary completion6 Feb 2019 (estimated)
- Study completion6 Apr 2019 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Louis Hospital, Paris, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri SOUSSI, Saint-Louis Hospital, Paris, France
- Investigators
- Sabri Soussi, MD, Principal investigator, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271268
- Sponsor's protocol ID
- StLouisFrance
- Acronym
- CAROLE
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 7 Sep 2017
- 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 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients
- ClinicalTrials.gov ID
- NCT03271268
- Acronym / sponsor ID
- CAROLE / StLouisFrance
- Conditions
- Burns
- Keywords
- Vascular filling, Fluid overload, Biomarkers, Lung edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Saint-Louis Hospital, Paris, FranceUniversity, hospital or other
- Study start
- 6 Aug 2017 (actual)
- Primary completion
- 6 Feb 2019 (estimated)
- Study completion
- 6 Apr 2019 (estimated)
- First posted
- 5 Sep 2017 (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.
Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.
The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .
Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severely ill burn patients admitted to a tertiary referral burn center
Key inclusion criteria (5 listed)
- Intubated mechanically-ventilated patients within the first 24 hours of admission
- And/or patients with total body surface area (TBSA) burn-injured >20 %
- And/or patients with at least 10% full-thickness burns
- And/or receiving vasopressors within the first 24 hours of admission
- And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)
Key exclusion criteria (8 listed)
- Admission delay to ICU > 24 hours post burn
- Age less than 18 years
- Pregnancy
- Chronic renal impairment with a baseline eGFR < 15 ml/min
- Patients with chemical or electrical burns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung edema
Time frame: During the first 7 days of admission
Extravascular lung water (EVLW) > 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)
7 secondary outcomes
Hypoxemia
Time frame: During the first 7 days of admission for mechanically-ventilated patients
Hypercapnia
Time frame: During the first 7 days of admission for mechanically-ventilated patients
Corrected minute ventilation > 10L/min
Time frame: During the first 7 days of admission for mechanically-ventilated patients
Multiple organ dysfunction syndrome (MODS)
Time frame: During the first 7 days of admission
28-day mortality
Time frame: 28 days
90-day mortality
Time frame: 90 days
Length of stay in the ICU
Time frame: until 90 days of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Soluble CD146, a new endothelial biomarker of acutely decompensated heart failureLink provided by the sponsor.
- Natriuretic peptide type B in burn intensive careLink provided by the sponsor.
- Plasma Levels of Soluble CD146 Reflect the Severity of Pulmonary Congestion Better Than Brain Natriuretic Peptide in Acute Coronary SyndromeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sabri Soussi, MD principal investigator
Saint-Louis Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Saint-Louis Hospital, Paris, France 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Sep 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabri Soussi, MD (0613064542 ext. +33, sabri.soussi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung edema (time frame: During the first 7 days of admission). 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 7 Sep 2017.