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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 8, 2014
Last verified: July 2014
  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:

Primary Outcome Measures:
  • Course of inflammatory parameters and lung function [ Time Frame: end of treatment ] [ Designated as safety issue: No ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 8, 2014
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 July 28, 2014