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CompletedNCT02486614CitrocoUpdated Oct 22, 2019

Effect of Citrate on the Coagulation System in Patients Receiving CRRT

An observational study in Acute Kidney Failure, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Kidney Failure
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 22 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adults with acute kidney injury requiring citrate based continuous renal replacement therapy

Inclusion criteria

  • acute kidney injury treated with citrate based continuous renal replacement therapy (CRRT)
  • age >18 years.
  • expected to require >72 hours of CRRT.

Exclusion criteria

Exclusion criteria:

  • 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
  • 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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Interventions

  • ProcedureCRRT

    citrate based continuous renal replacement therapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: Before initiation of CRRT

07

Study locations

1 site
  • Guy's & St Thomas Hospital
    London, SE1 7EH, United Kingdom
08

References and documents

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 35355147 ↗
  • Fisher 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02486614
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Responsible party
Sponsor
First posted
Jul 1, 2015
Start date
Jun 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Oct 22, 2019

Study contacts

Marlies Ostermann, PhD
principal investigator · Guy's & St Thomas' Foundation Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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