Effect of Citrate on the Coagulation System in Patients Receiving CRRT

Acute Kidney Failure Clinical Trial

— Citroco  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486614
• Other study ID #: RJ114/N168
• Status: Completed
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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).

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

Procedure:
• CRRT
citrate based continuous renal replacement therapy

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Before initiation of CRRT