Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

NCT ID: NCT03271268

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-06

Study Completion Date

2019-04-06

Brief Summary

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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.

Detailed Description

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Conditions

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Burns

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role lead

Responsible Party

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Sabri SOUSSI

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabri Soussi, MD

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

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Sabri SOUSSI

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sabri Soussi, MD

Role: CONTACT

0613064542 ext. +33

Matthieu Legrand, MD, PhD

Role: CONTACT

0685104235 ext. +33

Facility Contacts

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Sabri Soussi, MD

Role: primary

0613064542 ext. +33

Matthieu Legrand, MD, PhD

Role: backup

0685104235 ext. +33

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/23425748

Natriuretic peptide type B in burn intensive care

https://www.ncbi.nlm.nih.gov/pubmed/?term=Plasma+Levels+of+Soluble+CD146+Reflect+the+Severity+of+Pulmonary+Congestion+Better+Than+Brain+Natriuretic+Peptide+in+Acute+Coronary+Syndrome

Plasma Levels of Soluble CD146 Reflect the Severity of Pulmonary Congestion Better Than Brain Natriuretic Peptide in Acute Coronary Syndrome

Other Identifiers

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StLouisFrance

Identifier Type: -

Identifier Source: org_study_id

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