Cytokine Removal by CRRT in Pediatric Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

CRRT via Convection

Group Type ACTIVE_COMPARATOR

Continuous Renal Replacement Therapy

Intervention Type 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.

2

CRRT via Diffusion

Group Type ACTIVE_COMPARATOR

Continuous Renal Replacement Therapy

Intervention Type 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.

Interventions

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Continuous Renal Replacement Therapy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No