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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021665-68 | EudraCT Number |
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The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.
Objective : To compare the feasibility, safety and efficacy of Sustained Low Efficiency Daily Hemodialysis (SLEDD) using regional anticoagulation with Citrasate® compared to systemic anticoagulation with unfractionated heparin in critically ill patients.
Design : Prospective, randomized, single-center clinical trial Setting : mixed medical-surgical 45 bed ICU in a tertiary university hospital Patients : 250 patients with Acute Kidney Injury (AKI) stage III needing renal replacement therapy Interventions : Patients are randomized to receive SLEDD using standard dialysate and systemic anticoagulation with UF versus SLEDD using Citrasate®-dialysate with no additional UF.
Measurements and main results :
Primary end point :
- The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
Secondary end points :
Tertiary end points :
- All cause mortality at day 28 and day 90 after inclusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Anticoagulation | Active Comparator | Hemodialysis is performed using standard anticoagulation using unfractionated heparin if no contra-indications for the use of heparin exist. If contra-indications for heparin exist a heparin coated hemofilter (Evodial) will be used. The use of unfractionated heparin or no heparin (with coated hemofilter) is a decision to be taken before every hemodialysis. |
|
| Citrasate | Experimental | Hemodialysis is performed with Citrasate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unfractionated heparin | Drug | dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. | 6 hours after starting dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of technique failure defined as the number of patients who develop a contra-indication for the allocated anticoagulation regimen during the study period | during whole wtudy | |
| The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walter Verbrugghe, MD | Contact | 003238214149 | walter.verbrugghe@uza.be | |
| Philippe Jorens, PhD, MD | Contact | 003238213639 | philippe.jorens@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Karin Jansen-Van doorn, MD | Staff member Nephrology Department | Principal Investigator |
| Gert Verpooten, PhD, MD | Head of Nephrology Department, University Hospital Antwerp, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care Department of the Antwerp University Hospital, Belgium | Edegem | Edegem | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33314078 | Derived | Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Citrasate | Drug | Citrasate is infused as a dialysate |
|
|
| during the whole study period |
| The transfusion requirements defined as the total of units blood products administrated during the ICU stay and per dialysis treatment | during the whole study period |
| The incidence of metabolic derangements during the study period |
| during the whole study period |
| Dialysis efficiency expressed as Kt/V and URR | 6 hours after starting dialysis |
| Walter Verbrugghe, MD | Staff member Critical Care Department, Antwerp University Hospital, Belgium | Principal Investigator |
| Philippe Jorens, PhD, MD | Head of Critical Care Department, Antwerp University Hospital, Belgium | Principal Investigator |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |