A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation
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|ClinicalTrials.gov Identifier: NCT01318811|
Recruitment Status : Recruiting
First Posted : March 18, 2011
Last Update Posted : May 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury Acute Renal Failure Heart Failure||Drug: Dilute unfractionated heparin Drug: Standard concentration unfractionated heparin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Dilute Unfractionated Heparin and Standard Concentrated Unfractionated Heparin Protocols for Anticoagulation of the Extra-corporeal Circuit During Continuous Renal Replacement Therapy in the ICU|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: Dilute heparin
Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter.
Drug: Dilute unfractionated heparin
Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter.
Other Name: Heparin
Active Comparator: Standard concentrated heparin
Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter.
Drug: Standard concentration unfractionated heparin
Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl.
Other Name: Heparin
- Filter life [ Time Frame: 72 hours ]The primary endpoint for this study will be the difference in filter life in hours between the group receiving dilute heparin and the group receiving standard concentrated heparin.
- Bleeding complications [ Time Frame: 72 hours ]Information on minor bleeding complications, major bleeding complications, and need for blood product transfusions will be collected.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318811
|Contact: Thomas A Golper, MD||(615) firstname.lastname@example.org|
|Contact: Mohammed Sika, PhD||(615) email@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Thomas A Golper, MD 615-343-2220 firstname.lastname@example.org|
|Contact: Mohammed Sika, PhD (615) 936-2630 email@example.com|
|Principal Investigator: Thomas A Golper, MD|
|Principal Investigator:||Thomas A Golper, MD||Vanderbilt University|