Lung and Systemic Inflammation in the Critically Ill Patient

Terminated

• Conditions: Acute Respiratory Distress Syndrome (ARDS); Systemic Inflammatory Response Syndrome (SIRS); Sepsis

• Registration Number: NCT01906229
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. Sepsis, on the other hand, represents the systemic inflammatory response to an invading pathogen, which may inflict damage upon the host through organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high mortality, and both diseases involve a complex interplay of different inflammatory mediators and cell types. It has been suggested that locally released inflammatory mediators pass from the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely, it is possible that severe systemic inflammation may lead to ARDS by an influx of inflammatory mediators from the bloodstream to the lungs. However, the time course and the possible pathways for this transmission of disease have yet to be established.

Investigators hypothesize that:

1. Primary systemic inflammation is followed by a secondary pulmonary inflammatory response

2. Primary pulmonary inflammation is followed by a secondary systemic inflammatory response

3. Both primary and secondary inflammatory responses are characterized by the appearance of pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins (termed 'lectins')

4. The inflammatory response is most pronounced in the primary afflicted compartment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Status Verified: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

General:

• Age >18 years
• Mechanically ventilated
• < 48 hours after admission to the Intensive Care Unit

Specific:

-ARDS: acute (< 1 week) respiratory failure, characterized by hypoxemia (PaO2/FiO2 < 300 mmHg/40kPa), and bilateral infiltrates on x-ray or CT of thorax, that can not be explained by heart failure og overhydration.

OR

• SIRS (two of the following): Temperature > 38°C or < 36°C, heart rate > 90/min, respiratory frequency > 20 or PaCO2 < 4.2 kPa, leukocytosis (> 12x10^9/L) or leukopenia (< 4x10^9/L)

OR

ARDS + SIRS

Exclusion Criteria

One lung ventilation; Tube size < 8.0 mm; INR > 1.5 or thrombocytes < 40x10^9/L; Intracranial hypertension; Malignant arrythmias

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor necrosis factor alpha (TNF-a) bioactivity	Day fourteen

Secondary Outcome Measures

Name	Time	Method
Interleukin (IL)-6	Day one
Mannose binding lectin (MBL)	Day one
Ficolin-1,2,3	Day one

Trial Locations

Locations (1)

Intensive Care Unit, 4131, Rigshospitalet; 🇩🇰 Copenhagen Ø, Denmark