Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

Burns Clinical Trial

— CAROLE  

Official title:

The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271268
• Other study ID #: StLouisFrance
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 4, 2017
• Start date: August 6, 2017
• Est. completion date: April 6, 2019

Study information

• Verified date: September 2017
• Source: Saint-Louis Hospital, Paris, France
• Contact: Sabri Soussi, MD
• Phone: 0613064542
• Email: sabri.soussi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pulmonary Edema

Locations

Country	Name	City	State
France	Sabri SOUSSI	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung edema	Extravascular lung water (EVLW) > 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)	During the first 7 days of admission
Secondary	Hypoxemia	PaO2/FiO2 ratio of <200	During the first 7 days of admission for mechanically-ventilated patients
Secondary	Hypercapnia	PaCO2> 45 mmHg	During the first 7 days of admission for mechanically-ventilated patients
Secondary	Corrected minute ventilation > 10L/min	Minute ventilation × partial [Paco2]/40) > 10L/min	During the first 7 days of admission for mechanically-ventilated patients
Secondary	Multiple organ dysfunction syndrome (MODS)	Sequential Organ Failure Assessment score (SOFA) = 8	During the first 7 days of admission
Secondary	28-day mortality		28 days
Secondary	90-day mortality		90 days
Secondary	Length of stay in the ICU		until 90 days of hospitalization

External Links

•   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
•   Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure