Sorbent Treatment Prescriptions Pilot Study

NCT ID: NCT01437761

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-01-31

Brief Summary

This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.

Detailed Description

The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.

This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.

How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.

Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.

Conditions

Renal Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

2008 Sorbent system

Hemodialysis with the 2008 Sorbent system

2008 Sorbent System

Intervention Type: DEVICE

2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA).

Interventions

2008 Sorbent System

2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age </=18 years
• end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for </= 6 months at time of enrollment
• well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of >/= 300 mL/min
• ability to understand the English language

Exclusion Criteria

• Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
• Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
• Active Infections
• Hepatitis B
• Any other active infection that has required antibiotic treatment in the preceding eight weeks
• Pre-study lab values of any of the following (in the most recent routine lab work)
• Sodium - Na+ > 150 mmol/L, Na+ < 132 mmol/L
• Potassium - K+ > 6.5 mmol/L, K+ < 3.5 mmol/L
• Total Calcium - Ca > 12 mg/dL (3 mmol/L), total Ca < 7.2 mg/dL (1.8 mmol/L)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renal Solutions, Inc.

INDUSTRY

Sponsor Role: collaborator

Renal Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kotanko, MD

Role: PRINCIPAL_INVESTIGATOR

Renal Research Institute

Locations

Yorkville Dialysis Center

New York, New York, United States

Countries

United States

Other Identifiers

150-11

Identifier Type: -

Identifier Source: org_study_id