Hemodialysis Without Anticoagulation in Intensive Care Unit

Phase 3

• Conditions: Kidney Failure; Hemorrhage; Critically Ill

• Registration Number: NCT00242398
• Lead Sponsor: Centre Hospitalier Départemental

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-20
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-02
• Last Update Posted: 2007-10-03
• Study Completion: 2008-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• age > 18 years
• patient with high risk bleeding
• patient requiring dialytic therapy in intensive care unit

Exclusion Criteria

• Pregnancy
• History of heparin-induced thrombocytopenia or serious heparin allergy
• History of serious membrane dialysis allergy
• Treatment by any of following medications 24H within the inclusion:

prophylactic or therapeutic anticoagulation with unfractioned heparin or low molecular weight heparin nonsteroidal anti-inflammatory agents direct thrombin inhibitors, antithrombin concentrate, activated protein C, anti-factor Xa pentasaccharide

• Treatement by acetylsalicylic acid or other antiplatelet agent excluding platelet glycoprotein IIb/IIIa antagonists 7 days within the inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis.	at the end of the dialysis treatement

Secondary Outcome Measures

Name	Time	Method
Necessary time of nurse's work	During the dialysis treatment
Weight lost patients during dialysis treatment	At the end of dialysis treatment
Blood lost associated with extracorporeal thrombosis or active bleeding	At the end of the dialysis treatment

Trial Locations

Locations (1)

CHD; 🇫🇷 La Roche sur Yon, France