Hemofiltration for Respiratory Failure After Bone Marrow Transplantation
Recruitment status was Recruiting
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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 |
- Survival
- 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 |
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 |
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| Contact: Joseph V DiCarlo, MD | (650) 497-8850 | jdicarlo@stanford.edu |
| 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 | |
| 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 May 16, 2013