Trial record 6 of 248 for:    Open Studies | "Respiratory Insufficiency"

Hemofiltration for Respiratory Failure After Bone Marrow Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00120575
First received: July 11, 2005
Last updated: December 1, 2006
Last verified: December 2006
  Purpose

For children undergoing bone marrow transplantation, respiratory failure is a devastating complication, with mortality expectations well above 60%. The researchers have devised a novel strategy that may greatly improve survival. Hemofiltration, a continuous form of dialysis, was designed as a therapy for critically ill patients with kidney failure. A semi-permeable membrane removes plasma water and solutes (up to about 35,000 Daltons molecular weight). The researchers have treated immuno-compromised children with respiratory failure with hemofiltration. Many inflammatory molecules are of a size well below the limit of the filter. Hemofiltration might remove a critical amount of this inflammatory material, attenuating the unregulated inflammatory response that is central to the development of respiratory failure and progression to multiple organ failure and death. The researchers are conducting a multi-center trial of early continuous hemofiltration for respiratory failure in children following bone marrow transplantation. The researchers will analyze blood and ultrafiltrate using sensitive proteomic methods to detect several inflammatory biochemicals known to be active in this disease, looking for evidence that early active hemofiltration alters the inflammatory response. The researchers will test whether `early` hemofiltration produces greater survival from respiratory failure in this vulnerable population.


Condition Intervention Phase
Bone Marrow Transplantation
Respiratory Insufficiency
Procedure: hemofiltration
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemofiltration for Respiratory Failure Following Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • PELOD organ failure score
  • number of ventilator-free days
  • duration of hospitalization
  • functional outcome score

Estimated Enrollment: 112
Study Start Date: January 2005
Estimated Study Completion Date: September 2008
Detailed Description:

For children undergoing bone marrow transplantation, respiratory failure carries mortality expectations well above 60%. The researchers have published preliminary evidence that continuous hemofiltration may greatly improve survival, if filtration is begun when the child first fulfills clinical criteria for ARDS. This is a departure from standard practice, as hemofiltration is usually begun later in the course (if at all) when multiple organ failure is entrenched. Hemofiltration, a `renal replacement therapy` for critically ill patients, is a slow, continuous process in which a semi-permeable membrane removes plasma water and solutes (up to about 35 kiloDaltons). Many cytokine and chemokine molecules are smaller than the molecular weight limit of the filter; hemofiltration might remove a critical amount, attenuating the unregulated inflammatory response responsible for respiratory failure and progression to multiple organ failure and death. The researchers will conduct a multi-center randomized trial assessing the effect of hemofiltration on survival from respiratory after bone marrow (or more precisely, hematopoietic stem cell) transplantation. The researchers will perform sensitive proteomic assays of serum and ultrafiltrate, to detect the presence of cytokines and chemokines known to be active in idiopathic pneumonia syndrome. Resulting profiles will constitute a uniquely complex description of ultrafiltrate and may provide evidence for modulation of immune function by hemofiltration.

  Eligibility

Ages Eligible for Study:   1 Month to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hematopoietic stem cell recipient
  • respiratory failure fulfilling ARDS criteria
  • mechanical ventilation (invasive / non-invasive)

Exclusion Criteria:

  • extracorporeal membrane oxygenation (ECMO)
  • predominance of congestive heart failure
  • code status: a patient must be willing to accept invasive mechanical ventilation if clinically indicated
  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: NCT00120575

Contacts
Contact: Joseph V DiCarlo, MD (650) 497-8850 jdicarlo@stanford.edu

Locations
United States, California
Children's Hospital and Research Center Not yet recruiting
Oakland, California, United States, 94609
Contact: Vivienne Newman, MD         
Principal Investigator: Vivienne Newman, MD         
United States, Georgia
Children's Healthcare of Atlanta @ Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: James Fortenberry, MD         
Principal Investigator: James Fortenberry, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Ira Cheifetz, MD         
Principal Investigator: Ira Cheifetz, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vinay Nadkarni, MD         
Principal Investigator: Vinay Nadkarni, MD         
Canada, British Columbia
Children's Hospital of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Peter Skippen, MD         
Contact: Gordon Krahn         
Principal Investigator: Peter Skippen, MD         
Germany
University of Ulm Recruiting
Ulm, Germany
Contact: Helmut Hummler, MD         
Principal Investigator: Helmut Hummler, MD         
United Kingdom
Great Ormond Street Hospital Recruiting
London, United Kingdom
Contact: Quen Mok, MB BS         
Principal Investigator: Quen Mok, MB BS         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Joseph V DiCarlo, MD Stanford University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00120575     History of Changes
Other Study ID Numbers: BMT CVVH
Study First Received: July 11, 2005
Last Updated: December 1, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Hemofiltration
Pediatrics

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014