Clinical trial NCT01906229: Lung and Systemic Inflammation in the Critically Ill Patient
Official title: Acute Pulmonary and Systemic Inflammation in Mechanically Ventilated Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit

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.


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

Primary outcomes:
measure: Tumor necrosis factor alpha (TNF-a) bioactivity
timeFrame: Day one
measure: Tumor necrosis factor alpha (TNF-a) bioactivity
timeFrame: Day three
measure: Tumor necrosis factor alpha (TNF-a) bioactivity
timeFrame: Day seven
measure: Tumor necrosis factor alpha (TNF-a) bioactivity
timeFrame: Day fourteen
Secondary outcomes:
measure: Interleukin (IL)-6
timeFrame: Day one
measure: Mannose binding lectin (MBL)
timeFrame: Day one
measure: Ficolin-1,2,3
timeFrame: Day one
Other outcomes:
Locations:
city: Copenhagen Ø
country: Denmark
facility: Intensive Care Unit, 4131, Rigshospitalet
Study officials:
References: