Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients (CAROLE)

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.

Study Overview

• Status: Unknown
• Conditions: Burns

• Study Type: Observational
• Enrollment (Anticipated): 36

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Paris, Ile de France, France, 75010
      • Recruiting
      • Sabri SOUSSI
      • Contact: Sabri Soussi, MD; Phone Number: +33 0613064542; Email: sabri.soussi@gmail.com
      • Contact: Matthieu Legrand, MD, PhD; Phone Number: +33 0685104235; Email: matthieu.m.legrand@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severely ill burn patients admitted to a tertiary referral burn center

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung edema	Extravascular lung water (EVLW) > 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)	During the first 7 days of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality		28 days
90-day mortality		90 days
Hypoxemia	PaO2/FiO2 ratio of <200	During the first 7 days of admission for mechanically-ventilated patients
Hypercapnia	PaCO2> 45 mmHg	During the first 7 days of admission for mechanically-ventilated patients
Corrected minute ventilation > 10L/min	Minute ventilation × partial [Paco2]/40) > 10L/min	During the first 7 days of admission for mechanically-ventilated patients
Multiple organ dysfunction syndrome (MODS)	Sequential Organ Failure Assessment score (SOFA) ≥ 8	During the first 7 days of admission
Length of stay in the ICU		until 90 days of hospitalization

Collaborators and Investigators

• Sponsor: Saint-Louis Hospital, Paris, France
• Investigators: Principal Investigator: Sabri Soussi, MD, Saint-Louis Hospital, Paris, France

Publications and helpful links

Helpful Links

• Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure
• Natriuretic peptide type B in burn intensive care
• Plasma Levels of Soluble CD146 Reflect the Severity of Pulmonary Congestion Better Than Brain Natriuretic Peptide in Acute Coronary Syndrome

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2017
• Primary Completion (Anticipated): February 6, 2019
• Study Completion (Anticipated): April 6, 2019

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Biomarkers; Fluid overload; Vascular filling; Lung edema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Edema
• Other Study ID Numbers: StLouisFrance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No