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Lung and Systemic Inflammation in the Critically Ill Patient

Acute Pulmonary and Systemic Inflammation in Mechanically Ventilated Intensive Care Patients

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01906229
Enrollment
8
Registered
2013-07-24
Start date
2013-07-31
Completion date
2018-12-31
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Tumor necrosis factor alpha (TNF-a) bioactivityDay one

Secondary

MeasureTime frame
Interleukin (IL)-6Day one
Mannose binding lectin (MBL)Day one
Ficolin-1,2,3Day one

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026