Lung and Systemic Inflammation in the Critically Ill Patient

NCT01906229 | Terminated DMC

• 1 other identifier: 959521891
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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. 1.Primary systemic inflammation is followed by a secondary pulmonary inflammatory response
2. 2.Primary pulmonary inflammation is followed by a secondary systemic inflammatory response
3. 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. 4.The inflammatory response is most pronounced in the primary afflicted compartment.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Tumor necrosis factor alpha (TNF-a) bioactivity

  Day one

• Tumor necrosis factor alpha (TNF-a) bioactivity

  Day three

• Tumor necrosis factor alpha (TNF-a) bioactivity

  Day seven

• Tumor necrosis factor alpha (TNF-a) bioactivity

  Day fourteen

Secondary Outcomes (3)

• Interleukin (IL)-6

  Day one

• Mannose binding lectin (MBL)

  Day one

• Ficolin-1,2,3

  Day one

Study Arms (3)

Acute respiratory distress syndrome (ARDS)

Systemic inflammatory response syndrome (SIRS)

ARDS+SIRS

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

Intensive care unit

You may qualify if:

• 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.
• \- 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)
• ARDS + SIRS

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Intensive Care Unit, 4131, Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Systemic Inflammatory Response Syndrome; Sepsis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

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: July 16, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

DK (1)