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Completed

NCT Number: NCT00537693

Cytokine Removal by CRRT in Pediatric Sepsis

This pilot study will compare the effect of diffusive versus convective Continuous Renal Replacement Therapy (CRRT) in children with sepsis who require CRRT.

The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of cytokines and improved clinical responses as compared to a diffusive CRRT modality.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Medical Center, Washington D.C., District of Columbia, United States

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About this study

The purpose of this study is to test the hypothesis that convective forms of Continuous Renal Replacement Therapy (CRRT) provides enhanced clearance of cytokines compared to a diffusive CRRT modality. Also, we plan to test the hypothesis that patients who receive convective CRRT modalities demonstrate improved clinical responses to patients who receive a diffusive CRRT modality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with documented sepsis or suspected SIRS
  • Patients initiating CRRT
  • Age 1 to 21 years

Exclusion criteria

  • Patients on ECMO
  • Patients receiving concomitant plasma exchange
  • Cardiopulmonary bypass procedure within 96 hours of CRRT
  • Patients with new onset acute leukemia
  • Patients with active autoimmune disease
  • Ungrafted stem cell transplant recipients

Treatment and study plan

Continuous Renal Replacement Therapy

Procedure

Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.

Primary outcomes

  1. A 25% additional decrease in IL-6 concentration change

    Time frame: The First 24 hours of CRRT

Secondary outcomes

  1. Other cytokine removal rates

    Time frame: First 24 hours of CRRT

  2. Cytokine absorption on the CRRT membrane

    Time frame: First 24 hours of CRRT

  3. Hemodynamic parameters

    Time frame: First 24 hours of CRRT

  4. Changes in serum cytokine concentrations and clearance

    Time frame: After crossover, from 24-48 hours

  5. Changes in serum cytokine concentrations

    Time frame: From beginning to end of the study, independent of modality

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Dialysis Solutions Inc.

Registry information

Official study title

Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2007
Registry last updated
Sep 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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