Acute Kidney InjuryPhase 4NCT01228292
Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
A Phase 4 study testing Unfractionated heparin and Citrasate in people with Acute Kidney Injury and Hemodialysis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Hemodialysis
- What is being tested?
- Unfractionated heparin and Citrasate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need for hemodialysis in the ICU for at least one treatment
- No prior hemodialysis treatment in the ICU except continuous renal replacement therapy
Who cannot join
- Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
- Need for continued thrombolysis therapy within the 6 hours before inclusion
- Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
- Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
- Liver failure (acute and acute-on-chronic)
- Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
Show all 9Show fewer
- Heparin allergies
- Severe uncorrected hypocalcemia (ionized calcium < 0,8 mmol/l)
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Critical Care Department of the Antwerp University Hospital, Belgium
Edegem, Edegem, 2650
Walter Verbrugghe, MD, 003238214149, walter.Verbrugghe@uza.be
Philippe Jorens, PhD, MD, 003238213639, philippe.jorens@uza.be
About this study
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.
Read the 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
- Conditions
- Acute Kidney Injury, Hemodialysis
- Being tested
- Unfractionated heparin, Citrasate
- Keywords
- Anticoagulation, Intensive Care Medicine, Hemodialysis, Critical Ill Patients
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
Also called Unfractionated Heparin, LEO laboratories Ltd, MA #PL 0043/0041R
dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis
CitrasateDrug
Also called Citrasate, Advanced Renal Technologies, MA #K000792
Citrasate is infused as a dialysate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Unfractionated heparin |
| Citrasate | Experimental | Hemodialysis is performed with Citrasate Receives: Drug: Citrasate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
Measured: 6 hours after starting dialysis
Secondary outcomes (5)
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
Measured: during whole wtudy
The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria
Measured: 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
Measured: during the whole study period
The incidence of metabolic derangements during the study period
- Metabolic alkalosis (defined as a pH > 7,5 and a bicarbonate > 24 mmol/l)
- Metabolic acidosis (defined as a pH < 7,25 and a bicarbonate < 18 mmol/l)
- Hypocalcemia (defined as an ionized calcium < 0,9 mmol/l)
- Hypercalcemia (defined as an ionized calcium > 1,2 mol/l)
- Hypernatremia (defined as a Na+ > 145 mmol/l)
- Hyponatremia (defined a a Na+ < 130 mmol/l)
- Citrate toxicity (defined as a total calcium/ionized calcium ratio > 2,5)
Measured: during the whole study period
Dialysis efficiency expressed as Kt/V and URR
Measured: 6 hours after starting dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Investigators
- Karin Jansen-Van doorn, MD, Principal investigator, Staff member Nephrology DepartmentGert Verpooten, PhD, MD, Principal investigator, Head of Nephrology Department, University Hospital Antwerp, BelgiumWalter Verbrugghe, MD, Principal investigator, Staff member Critical Care Department, Antwerp University Hospital, BelgiumPhilippe Jorens, PhD, MD, Principal investigator, Head of Critical Care Department, Antwerp University Hospital, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228292
- Sponsor's protocol ID
- 10/27/179
- Other IDs
- 2010-021665-68
- Status last verified
- Sep 2010
- First submitted
- 25 Oct 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33314078
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT01228292
- Acronym / sponsor ID
- 10/27/179
- Conditions
- Acute Kidney Injury, Hemodialysis
- Keywords
- Anticoagulation, Intensive Care Medicine, Hemodialysis, Critical Ill Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Anticoagulation | Active comparator | Drug: Unfractionated heparinHemodialysis 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 | Drug: CitrasateHemodialysis is performed with Citrasate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Need for hemodialysis in the ICU for at least one treatment
- No prior hemodialysis treatment in the ICU except continuous renal replacement therapy
Key exclusion criteria (9 listed)
- Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
- Need for continued thrombolysis therapy within the 6 hours before inclusion
- Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
- Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
- Liver failure (acute and acute-on-chronic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparinAlso: Unfractionated Heparin, LEO laboratories Ltd, MA #PL 0043/0041Rdose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis | Drug | Standard Anticoagulation |
| CitrasateAlso: Citrasate, Advanced Renal Technologies, MA #K000792Citrasate is infused as a dialysate | Drug | Citrasate |
Primary outcome
The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
Time frame: 6 hours after starting dialysis
5 secondary outcomes
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
Time frame: during whole wtudy
The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria
Time frame: 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
Time frame: during the whole study period
The incidence of metabolic derangements during the study period
Time frame: during the whole study period
Dialysis efficiency expressed as Kt/V and URR
Time frame: 6 hours after starting dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
- Derived from this study: PubMed 33314078Tsujimoto 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Jansen-Van doorn, MD principal investigator
Staff member Nephrology Department
Gert Verpooten, PhD, MD principal investigator
Head of Nephrology Department, University Hospital Antwerp, Belgium
Walter Verbrugghe, MD principal investigator
Staff member Critical Care Department, Antwerp University Hospital, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unfractionated heparin and Citrasate in people with Acute Kidney Injury and Hemodialysis, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter Verbrugghe, MD (003238214149, walter.verbrugghe@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. (time frame: 6 hours after starting dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2010.