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Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)

NCT00943267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-03-16

No results posted yet for this study

Summary

Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of patients with severe sepsis. The biological effects of APC are pleiotropic, and can be roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived from animal studies indicates that local administration of rAPC into the lungs exerts local anti-inflammatory and anticoagulant effects. In this study we propose to study the potential of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS) induced lung inflammation and coagulation in humans.

Conditions

Interventions

DRUG

Drotrecogin alpha

Drotrecogin alpha is given intrabronchially by bronchoscopy at t=0

DRUG

Saline (NaCl 0.9%)

Normal saline is given intrabronchially by bronchoscopy at t=0

DRUG

Endotoxin

Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0

PROCEDURE

Bronchoscopy

Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage)

PROCEDURE

Blood sampling

Blood sampling is done by venapuncture at t=0 and t=6

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Tom Van der Poll, MD PhD · AMC/UvA Amsterdam

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-08-31
Completion
2011-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943267 on ClinicalTrials.gov