A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation

• Status: Terminated
• Trial end date: 2016-04-03
• Target enrollment: 0
• Participant gender: All

Summary

Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been validated. Our study will compare dilute heparin to a standard concentration of heparin. The investigators hypothesize that heparin delivered in a dilute solution will augment coating of the filter fibers with anticoagulants, decreasing clotting events and increasing filter life. By improving delivery of heparin to the filter and circuit, where clotting events can disrupt dialysis, less heparin would be required for the extra-corporeal circuit and thus less heparin would be delivered back to the patient with blood return from the machine. By exposing the patient to less heparin it is hypothesized that fewer bleeding events would occur, making the dialysis treatment safer. If more of the filter's fibers remain patent and the filter is functional for a longer period of time, the CRRT would also be more effective.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Age greater than 18 years

• Renal failure, electrolyte disturbance, or volume overload requiring continuous venovenous hemodialysis (CVVHD) as determined by the Nephrology consult service

Exclusion Criteria:

• Age less than 18 years

• Active bleeding

• Coagulopathy as defined by baseline INR > 1.8, aPTT > 45 seconds, or platelet count < 50 thousand/μL

• Active administration of systemic anticoagulation (such as warfarin, therapeutic unfractionated heparin, or therapeutic enoxaparin)

• Contraindication to heparin (allergy, thrombocytopenia with platelet count < 50, known or suspected heparin induced thrombocytopenia [HIT])

• Contraindication to systemic anticoagulation (recent surgical or other invasive procedure, significant bleeding disorder, concern for intracranial bleeding, or other contraindication as determined by treating physician)

• Administration of drotrecogin (Xigris™)

• Anticipated surgical or other invasive procedure that would necessitate withdrawal of anticoagulation within 72 hours

• Expected termination of continuous renal replacement therapy (CRRT) or death in < 24 hours

• The need for more than 500 cc an hour of IV fluids delivered proximal to the filter for the purpose of performing continuous venovenous hemofiltration (CVVH) or continuous venovenous hemodiafiltration (CVVHDF)