Cytokine Removal by CRRT in Pediatric Sepsis

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Sepsis

Treatments: Procedure: Continuous Renal Replacement Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00537693

H-21133

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

1

Active Comparator group

Description:

CRRT via Convection

Treatment:

Procedure: Continuous Renal Replacement Therapy

2

Active Comparator group

Description:

CRRT via Diffusion

Treatment:

Procedure: Continuous Renal Replacement Therapy