NCT02486614

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

June 10, 2015

Last Update Submit

October 21, 2019

Conditions

Acute Kidney Failure

Outcome Measures

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

    72 hours

Secondary Outcomes (1)

  • Determination of baseline coagulation status before initiation of citrate-based CRRT

    Before initiation of CRRT

Interventions

CRRTPROCEDURE

citrate based continuous renal replacement therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 35355147DERIVED

  • 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.

    PMID: 28969597DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marlies Ostermann, PhD

    Guy's & St Thomas' Foundation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

July 1, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)