Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

This study is currently recruiting participants.
Verified November 2013 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Bernhard Holzgraefe, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01468142
First received: November 7, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The purpose of this study is the observation of the course of

  • the mechanics of the respiratory system
  • the endexpiratory lung volume
  • and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.

Condition
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Child

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General hospitals, district hospitals, specialized hospitals,

Criteria

Inclusion Criteria:

  • patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy.

Exclusion Criteria:

  • malignant disease with a poor prognosis
  • massive intracranial bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468142

Contacts
Contact: Bernhard Holzgraefe, MD 004651778023 bernhard.holzgraefe@ki.se

Locations
Sweden
ECMO Centre Karolinska Recruiting
Solna, Stockholm, Sweden, 17176
Contact: Bernhard Holzgraefe, MD    +46851778023    bernhard.holzgraefe@ki.se   
Principal Investigator: Bernhard Holzgraefe, MD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Bernhard Holzgraefe, MD Karolinska University Hospital
Study Chair: Anders Larsson, PhD Uppsala University, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Bernhard Holzgraefe, Consultant, ECMO centre Karolinska, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01468142     History of Changes
Other Study ID Numbers: 2011/1282-31/1
Study First Received: November 7, 2011
Last Updated: November 20, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on April 16, 2014