A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

Official title:

Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181544
• Other study ID #: Gambro PI 2012
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: May 5, 2017
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 years of age or older

• Stable hemodialysis prescription prior to study enrollment

• Dialyzing through a native fistula or Gore-Tex graft

• Blood access must be able to provide a blood flow rate of 400 ml/min

Exclusion Criteria:

• Non-compliance with dialysis

• Hematocrit less than 28%

• Active Infection

• Diagnosis of Heparin-Induced Thrombocytopenia (HIT)

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis
• Renal Insufficiency

Intervention

Procedure:
• Heparin dose titration
Patients will begin the study using their currently prescribed heparin doses - both bolus and constant infusion - for three treatments to establish a baseline and provide information on inter-treatment variability in dialyzer clotting. Subsequently, the bolus and infusion rates will be titrated either upward or downward based on the Robbins-Monro process and an evaluation of dialyzer clotting during the preceding treatment. Heparin doses will be adjusted for a total of 30 dialyses.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Renal Products, Inc., University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (4)

Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.

Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76. — View Citation

Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.

Smith BP, Ward RA, Brier ME. Prediction of anticoagulation during hemodialysis by population kinetics and an artificial neural network. Artif Organs. 1998 Sep;22(9):731-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm	The objective is to titrate each patient's heparin dose to the level that achieves adequate anticoagulation for that patient as assessed by the change in blood compartment volume of the dialyzer from pre- to post-dialysis. The strategy that will be used is the Robbins-Monro stochastic approximation algorithm.	up to 8 weeks
Secondary	Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers	Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.	up to 8 weeks