Hemodialysis Without Anticoagulation in Intensive Care Unit
Recruitment status was Recruiting
The purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Heparin Free Hemodialysis for Patients With Bleeding High Risk in ICU. Randomized Study: Heparin Free Dialysis With Intermittent Saline Flushes Versus Heparin Free Dialysis With Nephral 400ST (AN69ST, Hospal, France)|
- Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis. [ Time Frame: at the end of the dialysis treatement ]
- Blood lost associated with extracorporeal thrombosis or active bleeding [ Time Frame: At the end of the dialysis treatment ]
- Necessary time of nurse's work [ Time Frame: During the dialysis treatment ]
- Weight lost patients during dialysis treatment [ Time Frame: At the end of dialysis treatment ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||April 2008|
Hemodialysis in patients who are at high risk of bleeding complications represents a challenge of balancing the needs for establishment of an adequately functioning extracorporeal circuit for dialytic therapy with the requirement of not exacerbating existing bleeding or precipitating bleeding in predisposed subjects.
Several methods of nonheparin dialysis have been used. The method most commonly used to effect such treatment is "saline flushing": saline boluses are delivred at frequent intervals. This method is far from optimal for several reasons, including failure to maintain a patent circuit in significant proportion of patients, an added logistic burden on dialysis nurses. An alternative method of avoiding systemic heparinization is priming the dialysis membrane with heparin before hemodialysis. The method is based on fact that AN69ST (Nephral 400ST , Hospal, France) dialysis membrane have a high affinity for binding heparin, and that the bound heparin exerts a localized antithrombotic effect without systemic spillover.
Comparison: heparin free hemodialysis with saline flushes compared heparin free hemodialysis with Nephral 400ST.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242398
|Contact: Laurent Martin-Lefèvre, MD||33(0)firstname.lastname@example.org|
|La Roche sur Yon, France, 85925|
|Contact: Laurent Martin-Lefevre|
|Principal Investigator: Laurent Martin-Lefèvre|
|Principal Investigator:||Laurent Martin-Lefèvre|