Acute Renal FailureCitrateNCT01361581
Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy
An observational study of Acute Renal Failure and Critical Illness, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. Data on significance of systemic gain of citrate and its relationship to method configuration are missing. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Renal Failure, Critical Illness
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2008to not given
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: critically ill intensive care patients
Who may be able to join
- Acute renal failure on continuous renal replacement therapy for more than 24 hours (CVVH or CVVHDF).
Who cannot join
- Absence of consent.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, 120 00
Martin Balik, A/Prof, martin.balik@post.cz
Martin Balik, MD, PhD
About this study
Citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. Data on significance of systemic gain of citrate and its relationship to method configuration are missing. Patient might also receive certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution is used. The authors test variable methods of indirect estimate of systemic dose of citrate which would allow to quantify the metabolic input without mostly unavailable measurements of citrate levels.
- Conditions
- Acute Renal Failure, Critical Illness
- Keywords
- Acute renal failure, Anticoagulation, Citrate, Haemodiafiltration, Haemofiltration, Renal replacement therapy
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACD (acid-citrate-dextrose) | Not described | |
| 4% trisodium citrate | Not described | |
| unfractionated heparin (UFH) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJan 2008
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 Renal FailureStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361581
- Sponsor's protocol ID
- NS/10014-4
- Acronym
- Citrate
- Status last verified
- May 2011
- First submitted
- 25 May 2011
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Zakharchenko M, Los F, Brodska H, Balik M. The Effects of High Level Magnesium Dialysis/Substitution Fluid on Magnesium Homeostasis under Regional Citrate Anticoagulation in Critically Ill. PLoS One. 2016 Jul 8;11(7):e0158179. doi: 10.1371/journal.pone.0158179. eCollection 2016.
PubMed 27391902Balik M, Zakharchenko M, Leden P, Otahal M, Hruby J, Polak F, Rusinova K, Stach Z, Tokarik M, Vavrova J, Jabor A, Oudemans-van Straaten HM. Bioenergetic gain of citrate anticoagulated continuous hemodiafiltration--a comparison between 2 citrate modalities and unfractionated heparin. J Crit Care. 2013 Feb;28(1):87-95. doi: 10.1016/j.jcrc.2012.06.003. Epub 2012 Aug 27.
PubMed 22951019
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01361581
- Acronym / sponsor ID
- Citrate / NS/10014-4
- Conditions
- Acute Renal Failure, Critical Illness
- Keywords
- Acute renal failure, Anticoagulation, Citrate, Haemodiafiltration, Haemofiltration, Renal replacement therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- Jan 2008
- First posted
- 27 May 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.
Citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. Data on significance of systemic gain of citrate and its relationship to method configuration are missing. Patient might also receive certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution is used. The authors test variable methods of indirect estimate of systemic dose of citrate which would allow to quantify the metabolic input without mostly unavailable measurements of citrate levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACD (acid-citrate-dextrose) | – | – |
| 4% trisodium citrate | – | – |
| unfractionated heparin (UFH) | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- critically ill intensive care patients
Key inclusion criteria (1 listed)
- Acute renal failure on continuous renal replacement therapy for more than 24 hours (CVVH or CVVHDF).
Key exclusion criteria (1 listed)
- Absence of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
- Derived from this study: PubMed 27391902Zakharchenko M, Los F, Brodska H, Balik M. The Effects of High Level Magnesium Dialysis/Substitution Fluid on Magnesium Homeostasis under Regional Citrate Anticoagulation in Critically Ill. PLoS One. 2016 Jul 8;11(7):e0158179. doi: 10.1371/journal.pone.0158179. eCollection 2016.
- Derived from this study: PubMed 22951019Balik M, Zakharchenko M, Leden P, Otahal M, Hruby J, Polak F, Rusinova K, Stach Z, Tokarik M, Vavrova J, Jabor A, Oudemans-van Straaten HM. Bioenergetic gain of citrate anticoagulated continuous hemodiafiltration--a comparison between 2 citrate modalities and unfractionated heparin. J Crit Care. 2013 Feb;28(1):87-95. doi: 10.1016/j.jcrc.2012.06.003. Epub 2012 Aug 27.
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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.
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure and Critical Illness, run by Charles University, Czech Republic at 1 site in Czechia.
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 1 inclusion and 1 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 27 May 2011. 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 Czechia. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01361581, 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 27 May 2011.