Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

• Conditions: Burns

• Registration Number: NCT03271268
• Lead Sponsor: Saint-Louis Hospital, Paris, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-06
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-07
• Primary Completion: 2019-02-06
• Study Completion: 2019-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung edema	During the first 7 days of admission	Extravascular lung water (EVLW) \> 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sabri SOUSSI; 🇫🇷 Paris, Ile de France, France