Acute Kidney FailureCitrocoNCT02486614
Effect of Citrate on the Coagulation System in Patients Receiving CRRT
An observational study of Acute Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- CRRT
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with acute kidney injury requiring citrate based continuous renal replacement therapy
Who may be able to join
- acute kidney injury treated with citrate based continuous renal replacement therapy (CRRT)
- age >18 years.
- expected to require >72 hours of CRRT.
Who cannot join
- Known preexisting clotting tendency
- Known preexisting bleeding tendency
- Disseminated Intravascular Coagulation (DIC)
- Prior transfusion of any blood product in the 24 hours before enrolment
- Active bleeding (ie. needing blood transfusion) at time of enrolment
- Haemoglobin at time of enrolment <75g/L
Show all 13Show fewer
- Haematocrit at time of enrolment >0.55
- Patient would refuse Red Blood Cell transfusion (for example Jehova's Witness).
- Platelet count at time of enrolment <100x103/µL
- Treatment with any anticoagulant or antiplatelet agent at time of enrolment or within 7 days of enrolment with the exception of heparin or low molecular weight heparin for DVT prophylaxis.
- Intravenous heparin exposure within 4 hours of commencing citrate anticoagulation.
- Malnourished: BMI <18.5kg/m2 or unplanned weight loss >10% actual body weight (ABW) in preceding 6 months or BMI <20kg/m2 and unplanned weight loss >5% ABW in preceding 6 months.
- CRRT prescribed for an indication other than AKI (for example poisoning).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Regional Citrate Anti-coagulation on the Coagulation System in Critically Ill Patients Receiving Continuous Renal Replacement Therapy for Acute Kidney Injury - an Observational Cohort Study
The aim of this study is to evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury. This will form the basis for future studies where the investigators plan to focus on patients with premature circuit clotting despite optimal post-filtrate ionised calcium parameters.
Read the detailed description
Purpose of clinical trial:
To evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury.
Patient population:
critically ill patients with acute kidney injury requiring citrate-based continuous renal replacement therapy (CRRT)
Primary objective:
Changes from baseline in a number of measures of coagulability (platelet count; Prothrombin Time; Activated Partial Thromboplastin Time ratio; fibrinogen; d-dimers; Thrombin generation assay; Clot lysis; platelet function analysis 100) in both the blood within the patient's systemic circulation and the CRRT circuit over the course of 72 hours of regional anticoagulation with citrate.
Number of Subjects/Patients:
12 patients with complete data.
Trial Design:
Prospective non-interventional study.
Endpoints:
Change from baseline in a number of measures of coagulability.
Main Inclusion Criteria:
Adult intensive care patients undergoing CRRT with citrate regional anti-coagulation for AKI.
- Conditions
- Acute Kidney Failure
- Being tested
- CRRT
- 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.
CRRTProcedure or surgery
citrate based continuous renal replacement therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of parameters of coagulability during Continuous Renal Replacement Therapy (CRRT) with citrate anticoagulation
Changes of coagulation parameters (Full Blood Count, prothrombin time, activated partial thromboplastin time ratio, fibrinogen, d-dimer, thrombin generation, clot lysis and platelet function analysis) during citrate-based CRRT
Measured: 72 hours
Secondary outcomes (1)
Determination of baseline coagulation status before initiation of citrate-based CRRT
Determination of parameters of coagulation [Full Blood Count (FBC), prothrombin time (PT), activated partial thromboplastin time ratio (APTTr), fibrinogen, D-dimers, antithrombin activity, protein C activity, free Protein S antigen, resistance to activated protein C screening, homocysteine, prothrombin 20210 mutation test, factor VIII level, Von Willebrand factor antigen, Dilute Russell's Viper Venom Time, dilute activated partial thromboplastin time, anticardiolipin antibodies, anti-beta 2 glycoprotein I antibodies, thrombin generation assay, clot lysis, platelet function 1+2, Thrombin-Antithrombin and platelet function analysis] before initiation of citrate-based CRRT
Measured: Before initiation of CRRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
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 FailureStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlies Ostermann, PhD, Principal investigator, Guy's & St Thomas' Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486614
- Sponsor's protocol ID
- RJ114/N168
- Acronym
- Citroco
- Status last verified
- Oct 2019
- First submitted
- 10 Jun 2015
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fisher R, Moore GW, Mitchell MJ, Dai L, Crichton S, Lumlertgul N, Ostermann M. Effects of regional citrate anticoagulation on thrombin generation, fibrinolysis and platelet function in critically ill patients receiving continuous renal replacement therapy for acute kidney injury: a prospective study. Ann Intensive Care. 2022 Mar 31;12(1):29. doi: 10.1186/s13613-022-01004-w.
PubMed 35355147Fisher R, Lei K, Mitchell MJ, Moore GW, Dickie H, Tovey L, Crichton S, Ostermann M. The effect of regional citrate anti-coagulation on the coagulation system in critically ill patients receiving continuous renal replacement therapy for acute kidney injury - an observational cohort study. BMC Nephrol. 2017 Oct 2;18(1):304. doi: 10.1186/s12882-017-0718-z.
PubMed 28969597
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regional Citrate Anti-coagulation on the Coagulation System in Critically Ill Patients Receiving Continuous Renal Replacement Therapy for Acute Kidney Injury - an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02486614
- Acronym / sponsor ID
- Citroco / RJ114/N168
- Conditions
- Acute Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jul 2015 (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 aim of this study is to evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury. This will form the basis for future studies where the investigators plan to focus on patients with premature circuit clotting despite optimal post-filtrate ionised calcium parameters.
Detailed description
Purpose of clinical trial:
To evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury.
Patient population:
critically ill patients with acute kidney injury requiring citrate-based continuous renal replacement therapy (CRRT)
Primary objective:
Changes from baseline in a number of measures of coagulability (platelet count; Prothrombin Time; Activated Partial Thromboplastin Time ratio; fibrinogen; d-dimers; Thrombin generation assay; Clot lysis; platelet function analysis 100) in both the blood within the patient's systemic circulation and the CRRT circuit over the course of 72 hours of regional anticoagulation with citrate.
Number of Subjects/Patients:
12 patients with complete data.
Trial Design:
Prospective non-interventional study.
Endpoints:
Change from baseline in a number of measures of coagulability.
Main Inclusion Criteria:
Adult intensive care patients undergoing CRRT with citrate regional anti-coagulation for AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with acute kidney injury requiring citrate based continuous renal replacement therapy
Key inclusion criteria (3 listed)
- acute kidney injury treated with citrate based continuous renal replacement therapy (CRRT)
- age >18 years.
- expected to require >72 hours of CRRT.
Key exclusion criteria (13 listed)
- Known preexisting clotting tendency
- Known preexisting bleeding tendency
- Disseminated Intravascular Coagulation (DIC)
- Prior transfusion of any blood product in the 24 hours before enrolment
- Active bleeding (ie. needing blood transfusion) at time of enrolment
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 |
|---|---|---|
| CRRTcitrate based continuous renal replacement therapy | Procedure or surgery | – |
Primary outcome
Changes of parameters of coagulability during Continuous Renal Replacement Therapy (CRRT) with citrate anticoagulation
Time frame: 72 hours
Changes of coagulation parameters (Full Blood Count, prothrombin time, activated partial thromboplastin time ratio, fibrinogen, d-dimer, thrombin generation, clot lysis and platelet function analysis) during citrate-based CRRT
1 secondary outcome
Determination of baseline coagulation status before initiation of citrate-based CRRT
Time frame: Before initiation of CRRT
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 22 Oct 2019.
- Derived from this study: PubMed 35355147Fisher R, Moore GW, Mitchell MJ, Dai L, Crichton S, Lumlertgul N, Ostermann M. Effects of regional citrate anticoagulation on thrombin generation, fibrinolysis and platelet function in critically ill patients receiving continuous renal replacement therapy for acute kidney injury: a prospective study. Ann Intensive Care. 2022 Mar 31;12(1):29. doi: 10.1186/s13613-022-01004-w.
- Derived from this study: PubMed 28969597Fisher R, Lei K, Mitchell MJ, Moore GW, Dickie H, Tovey L, Crichton S, Ostermann M. The effect of regional citrate anti-coagulation on the coagulation system in critically ill patients receiving continuous renal replacement therapy for acute kidney injury - an observational cohort study. BMC Nephrol. 2017 Oct 2;18(1):304. doi: 10.1186/s12882-017-0718-z.
- Individual participant dataSharing planned: No
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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.
Marlies Ostermann, PhD principal investigator
Guy's & St Thomas' Foundation Hospital
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 Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 13 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 22 Oct 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 United Kingdom. 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?
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?
Changes of parameters of coagulability during Continuous Renal Replacement Therapy (CRRT) with citrate anticoagulation (time frame: 72 hours). 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 NCT02486614, 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 22 Oct 2019.