Lung and Systemic Inflammation in the Critically Ill Patient

NCT ID: NCT01906229

Last Updated: 2018-12-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute respiratory distress syndrome (ARDS)

No interventions assigned to this group

Systemic inflammatory response syndrome (SIRS)

No interventions assigned to this group

ARDS+SIRS

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Ronni R. Plovsing

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Intensive Care Unit, 4131, Rigshospitalet

Copenhagen Ø, , Denmark

Countries

Denmark

Other Identifiers

959521891

Identifier Type: -

Identifier Source: org_study_id