Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

NCT03271268 | Unknown

• 1 other identifier: StLouisFrance
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Vascular filling; Fluid overload; Biomarkers; Lung edema

Outcome Measures

Primary Outcomes (1)

• Lung edema

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

  During the first 7 days of admission

Secondary Outcomes (7)

• Hypoxemia

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

• Hypercapnia

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

• Corrected minute ventilation > 10L/min

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

• Multiple organ dysfunction syndrome (MODS)

  During the first 7 days of admission

• 28-day mortality

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severely ill burn patients admitted to a tertiary referral burn center

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Louis Hospital, Paris, France: lead

Study Sites (1)

Sabri SOUSSI

Paris, Île-de-France Region, 75010, France

RECRUITING

Related 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum bank : 1 sample (5 ml of blood): on admission and from day 1 to day 7 of admission.

MeSH Terms

Conditions

Burns; Edema; Pulmonary Edema

Condition Hierarchy (Ancestors)

Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sabri Soussi, MD

  Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabri Soussi, MD

CONTACT

0613064542; sabri.soussi@gmail.com

Matthieu Legrand, MD, PhD

CONTACT

0685104235; matthieu.m.legrand@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: August 6, 2017
• Primary Completion: February 6, 2019
• Study Completion: April 6, 2019
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)