ClinicalTrials.gg
Status unknownNCT03271268CAROLEUpdated Sep 7, 2017

Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

An observational study in Burns, sponsored by Saint-Louis Hospital, Paris, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by Saint-Louis Hospital, Paris, France · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Burns with a site in France — 6 open to participants now, 7 under way, 2 of them phase 3. Burns · France.

Planned enrollment
8th of 10
36 · median 72
Started
2017
with 2 others
Observational
10 of 32
2 open now
Registered
20th of 32
by date
Lead sponsor
2 of 32
Saint-Louis Hospital, Paris, France

Among the 32 studies in Burns with a site in France, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 3 that started in 2017, is one of 10 observational ones, and was the 20th registered.

Burns

906 studies on the registry are indexed under Burns; 165 are open to participants now.

Browse Burns studies →

Open to participants now

6 of the 32 studies in Burns with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

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.

03

Conditions studied

  • Burns

Keywords

  • Vascular filling
  • Fluid overload
  • Biomarkers
  • Lung edema
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Severely ill burn patients admitted to a tertiary referral burn center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Admission delay to ICU > 24 hours post burn
  • Age less than 18 years
  • Pregnancy
  • Chronic renal impairment with a baseline \< 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Lung edema

    Extravascular lung water (EVLW) \> 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)

    Time frame: During the first 7 days of admission

Secondary outcomes

  1. Hypoxemia

    PaO2/FiO2 ratio of \<200

    Time frame: During the first 7 days of admission for mechanically-ventilated patients

  2. Hypercapnia

    PaCO2\> 45 mmHg

    Time frame: During the first 7 days of admission for mechanically-ventilated patients

  3. Corrected minute ventilation > 10L/min

    Minute ventilation × partial \[Paco2\]/40) \> 10L/min

    Time frame: During the first 7 days of admission for mechanically-ventilated patients

  4. Multiple organ dysfunction syndrome (MODS)

    Sequential Organ Failure Assessment score (SOFA) ≥ 8

    Time frame: During the first 7 days of admission

  5. 28-day mortality

    Time frame: 28 days

  6. 90-day mortality

    Time frame: 90 days

  7. Length of stay in the ICU

    Time frame: until 90 days of hospitalization

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Feb 2019, 18 months after the start.

Of 56 non-industry observational studies under Burns, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 56. This study's planned 18 months is below that.

Counting every sponsor, half of 68 studies reached it within 24 months; a quarter within 14 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2017
First posted
Sep 5, 2017
StartActual
Aug 6, 2017
Primary completionEst.
Feb 6, 2019
CompletionEst.
Apr 6, 2019
Last update
Sep 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03271268
Lead sponsor
Saint-Louis Hospital, Paris, France
Responsible party
Sabri SOUSSI (MD, Saint-Louis Hospital, Paris, France) — Principal investigator
First posted
Sep 5, 2017
Start date
Aug 6, 2017
Primary completion
Feb 6, 2019 (estimated)
Completion
Apr 6, 2019 (estimated)
Last update
Sep 7, 2017

Study contacts

Sabri Soussi, MD
Contact
sabri.soussi@gmail.com
0613064542 ext. +33
Matthieu Legrand, MD, PhD
Contact
matthieu.m.legrand@gmail.com
0685104235 ext. +33
Sabri Soussi, MD
principal investigator · Saint-Louis Hospital, Paris, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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