Acute Kidney InjuryPhase 4NCT01269112
Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy
A Phase 4 study testing citrate regional anticoagulation in people with Acute Kidney Injury, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- citrate regional anticoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Nov 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
- Patients with acute kidney injury requiring renal replacement therapy (RIFLE criteria)
- Patients (males or females) > 18 yrs old
- Consent form signed (or in emergency investigator's statement form)
Who cannot join
- Patients with active bleeding disorders
- Patients with past history of heparin-induced thrombocytopenia (HIT)
- Patients with very severe liver disease ( patients awaiting liver transplant or factor V < 20% or MELD score > 25)
- Pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion)
- Enrollment in another concurrent therapeutic trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial
Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.
The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.
Read the detailed description
monocentric prospective open-label randomized controlled trial at the ICU of the University Hospitals of Geneva (Switzerland).
ICU patients eligible if they 18 yr old and had an AKI requiring CRRT Exclusion criteria Patients excluded if they had active hemorrhagic disorders or severe thrombocytopenia (< 50x109/L), a history of heparin-induced thrombocytopenia, severe liver failure defined as a factor V <20% or were on the waiting list for liver transplantation.
Treatment assignment Subjects enrolled into the trial randomly allocated to either heparin or citrate anticoagulation
- Conditions
- Acute Kidney Injury
- Being tested
- citrate regional anticoagulation
- 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.
citrate regional anticoagulationDevice
Patients randomly allocated to 2 treatment groups:
Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation
citrate regional anticoagulationDevice
Patients randomly allocated to 2 treatment groups:
Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| heparin | Placebo comparator | CVVHDF performed using unfractionated heparin as anticoagulant and Prismasol as reinjection and dialysate fluids Receives: Device: citrate regional anticoagulation |
| citrate regional anticoagulation | Active comparator | CVVHDF performed using Prismocitrate 18/0 solution (Trisodium citrate 18 mmol/L Receives: Device: citrate regional anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily dialysis delivered dose during intensive care stay
- Mean daily delivered dose during intensive care stay
- Filter life span
Measured: dialysis days during intensive care stay
Secondary outcomes (1)
patient survival
Measured: 28-day and 90-day patient survivals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Saudan, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269112
- Sponsor's protocol ID
- 09-069(NAC 09-27)
- Status last verified
- May 2016
- First submitted
- 3 Jan 2011
- Last updated
- 14 Aug 2019
- 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 33314078Stucker F, Ponte B, Tataw J, Martin PY, Wozniak H, Pugin J, Saudan P. Efficacy and safety of citrate-based anticoagulation compared to heparin in patients with acute kidney injury requiring continuous renal replacement therapy: a randomized controlled trial. Crit Care. 2015 Mar 18;19(1):91. doi: 10.1186/s13054-015-0822-z.
PubMed 25881975
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01269112
- Acronym / sponsor ID
- 09-069(NAC 09-27)
- Conditions
- Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Jan 2011 (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.
Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.
The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.
Detailed description
monocentric prospective open-label randomized controlled trial at the ICU of the University Hospitals of Geneva (Switzerland).
ICU patients eligible if they 18 yr old and had an AKI requiring CRRT Exclusion criteria Patients excluded if they had active hemorrhagic disorders or severe thrombocytopenia (< 50x109/L), a history of heparin-induced thrombocytopenia, severe liver failure defined as a factor V <20% or were on the waiting list for liver transplantation.
Treatment assignment Subjects enrolled into the trial randomly allocated to either heparin or citrate anticoagulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heparin | Placebo comparator | Device: citrate regional anticoagulationCVVHDF performed using unfractionated heparin as anticoagulant and Prismasol as reinjection and dialysate fluids |
| citrate regional anticoagulation | Active comparator | Device: citrate regional anticoagulationCVVHDF performed using Prismocitrate 18/0 solution (Trisodium citrate 18 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute kidney injury requiring renal replacement therapy (RIFLE criteria)
- Patients (males or females) > 18 yrs old
- Consent form signed (or in emergency investigator's statement form)
Key exclusion criteria (5 listed)
- Patients with active bleeding disorders
- Patients with past history of heparin-induced thrombocytopenia (HIT)
- Patients with very severe liver disease ( patients awaiting liver transplant or factor V < 20% or MELD score > 25)
- Pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion)
- Enrollment in another concurrent therapeutic trial
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 |
|---|---|---|
| citrate regional anticoagulationPatients randomly allocated to 2 treatment groups: Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation | Device | heparin |
| citrate regional anticoagulationPatients randomly allocated to 2 treatment groups: Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation | Device | citrate regional anticoagulation, heparin |
Primary outcome
Mean daily dialysis delivered dose during intensive care stay
Time frame: dialysis days during intensive care stay
* Mean daily delivered dose during intensive care stay * Filter life span
1 secondary outcome
patient survival
Time frame: 28-day and 90-day patient survivals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- 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.
- Derived from this study: PubMed 25881975Stucker F, Ponte B, Tataw J, Martin PY, Wozniak H, Pugin J, Saudan P. Efficacy and safety of citrate-based anticoagulation compared to heparin in patients with acute kidney injury requiring continuous renal replacement therapy: a randomized controlled trial. Crit Care. 2015 Mar 18;19(1):91. doi: 10.1186/s13054-015-0822-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 citrate regional anticoagulation in people with Acute Kidney Injury, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2019. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily dialysis delivered dose during intensive care stay (time frame: dialysis days during intensive care stay). 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 NCT01269112, which also lists 2 linked publications.
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 14 Aug 2019.