NCT00120575

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
4 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 5, 2006

Status Verified

December 1, 2006

First QC Date

July 11, 2005

Last Update Submit

December 1, 2006

Conditions

Bone Marrow TransplantationRespiratory Insufficiency

Keywords

HemofiltrationPediatrics

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (4)

  • PELOD organ failure score

  • number of ventilator-free days

  • duration of hospitalization

  • functional outcome score

Interventions

hemofiltrationPROCEDURE

Eligibility Criteria

Age1 Month - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Children's Hospital and Research Center

Oakland, California, 94609, United States

NOT YET RECRUITING

Children's Healthcare of Atlanta @ Egleston

Atlanta, Georgia, 30322, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Children's Hospital of British Columbia

Vancouver, British Columbia, Canada

NOT YET RECRUITING

University of Ulm

Ulm, Germany

RECRUITING

Great Ormond Street Hospital

London, United Kingdom

RECRUITING

Related Publications (2)

  • DiCarlo JV, Alexander SR, Agarwal R, Schiffman JD. Continuous veno-venous hemofiltration may improve survival from acute respiratory distress syndrome after bone marrow transplantation or chemotherapy. J Pediatr Hematol Oncol. 2003 Oct;25(10):801-5. doi: 10.1097/00043426-200310000-00012.

    PMID: 14528104BACKGROUND

  • Di Carlo JV, Alexander SR. Hemofiltration for cytokine-driven illnesses: the mediator delivery hypothesis. Int J Artif Organs. 2005 Aug;28(8):777-86. doi: 10.1177/039139880502800803.

    PMID: 16211527BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Hemofiltration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Joseph V DiCarlo, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph V DiCarlo, MD

CONTACT

(650) 497-8850jdicarlo@stanford.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 18, 2005

Study Start

January 1, 2005

Study Completion

September 1, 2008

Last Updated

December 5, 2006

Record last verified: 2006-12

Locations

US(4)DE(1)CA(1)GB(1)