Comparison of Conventional Dialysis and the Allient System

NCT00788905 | Unknown

• 1 other identifier: 065-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.

Conditions

End Stage Renal Disease; Chronic Kidney Failure

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Clearance of specific waste products from blood determined through subject blood and dialysate samples

  3 weeks

Secondary Outcomes (2)

• Inflammation as determined by levels of specific inflammatory markers

  3 weeks

• Red blood cell lifespan determined through a measurement of CO in the subject's breath

  3 weeks

Study Arms (1)

A

EXPERIMENTAL

Subject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase).

Device: Allient System

Interventions

Allient System DEVICE

The Allient System uses a different type of blood pump and a lower volume of dialysate.

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maintenance in-center hemodialysis
• Age greater than or equal to 18 years
• Has been on hemodialysis for at least 4 months
• Uses a standard single-pass dialysis machine with a high-flux dialyzer

You may not qualify if:

• Hospitalization during the 8 weeks preceding enrollment
• Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
• Central venous cather as dialysis access
• Uncontrollable blood coagulation anomalies
• Smokers
• Dialysis regimen other than 3 times weekly
• In ability to understand the English language and give informed consent for participation in the study

Sponsors & Collaborators

• Renal Research Institute: lead
• Renal Solutions, Inc.: collaborator

Study Sites (3)

Irving Place Dialysis Center

New York, New York, 10003, United States

Location

Upper Manhattan Dialysis Center

New York, New York, 10025, United States

Location

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

Related Publications (1)

• Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212.

  PMID: 25710773 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan W. Levin, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

• Peter Kotanko, MD

  Renal Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: November 11, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2014
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

US (3)