Lung and Systemic Inflammation in the Critically Ill Patient

Sepsis Clinical Trial

Official title:

Acute Pulmonary and Systemic Inflammation in Mechanically Ventilated Intensive Care Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01906229
• Other study ID #: 959521891
• Status: Terminated
• Start date: July 2013
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Inflammation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Syndrome
• Systemic Inflammatory Response Syndrome
• Systemic Inflammatory Response Syndrome (SIRS)

Locations

Country	Name	City	State
Denmark	Intensive Care Unit, 4131, Rigshospitalet	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor necrosis factor alpha (TNF-a) bioactivity		Day one
Primary	Tumor necrosis factor alpha (TNF-a) bioactivity		Day three
Primary	Tumor necrosis factor alpha (TNF-a) bioactivity		Day seven
Primary	Tumor necrosis factor alpha (TNF-a) bioactivity		Day fourteen
Secondary	Interleukin (IL)-6		Day one
Secondary	Mannose binding lectin (MBL)		Day one
Secondary	Ficolin-1,2,3		Day one