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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468142
First Posted: November 9, 2011
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bernhard Holzgraefe, Karolinska University Hospital
  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 Bernhard Holzgraefe, Karolinska University Hospital:

Primary Outcome Measures:
  • Course of inflammatory parameters and lung function [ Time Frame: end of treatment ]

Enrollment: 6
Study Start Date: February 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468142


Locations
Sweden
ECMO Centre Karolinska
Solna, Stockholm, Sweden, 17176
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

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
First Submitted: November 7, 2011
First Posted: November 9, 2011
Last Update Posted: December 20, 2016
Last Verified: December 2016

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