Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 12:23 PM
Study NCT ID:
NCT01228292
Status:
UNKNOWN
Last Update Posted:
2010-10-26
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Sponsor:
University Hospital, Antwerp
Organization:
Study Overview
Official Title:
Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 :
* The incidence of bleeding episodes as defined by the WHO-criteria
* The transfusion requirements
* The incidence of technique failure
* The incidence of metabolic derangements (metabolic alkalosis, metabolic acidosis, hypocalcemia, hypercalcemia, hypernatremia, hyponatremia)
* The incidence of citrate intoxication
* The dialysis efficiency expressed as Kt/V and URR
Tertiary end points :
\- All cause mortality at day 28 and day 90 after inclusion
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 :
* The incidence of bleeding episodes as defined by the WHO-criteria
* The transfusion requirements
* The incidence of technique failure
* The incidence of metabolic derangements (metabolic alkalosis, metabolic acidosis, hypocalcemia, hypercalcemia, hypernatremia, hyponatremia)
* The incidence of citrate intoxication
* The dialysis efficiency expressed as Kt/V and URR
Tertiary end points :
\- All cause mortality at day 28 and day 90 after inclusion
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-021665-68 | EUDRACT_NUMBER | None | View |