Cytokine Removal by CRRT in Pediatric Sepsis | NCT00537693

Studies
Cytokine Removal by CRRT in Pediatric Sepsis

NCT00537693

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Sep 2, 2010Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Sepsis

Interventions

Continuous Renal Replacement Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Sep 27, 2007

First Submission Date that Met QC Criteria

Sep 27, 2007

First Posted Date

Oct 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2010

Last Update Posted Date

Sep 2, 2010Estimated

Name	Class
Dialysis Solutions Inc.	INDUSTRY

Description Module

Brief Summary

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	CRRT via Convection	Procedure: Continuous Renal Replacement Therapy
2	Active Comparator	CRRT via Diffusion	Procedure: Continuous Renal Replacement Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A 25% additional decrease in IL-6 concentration change		The First 24 hours of CRRT

Secondary Outcomes

Measure	Description	Time Frame
Other cytokine removal rates		First 24 hours of CRRT
Cytokine absorption on the CRRT membrane		First 24 hours of CRRT
Hemodynamic parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Goldstein, MD	Baylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Medical Center		Washington D.C.	District of Columbia	20010	United States
All Children's Hospital

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079664	Continuous Renal Replacement Therapy

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided