Effect of Citrate on the Coagulation System in Patients Receiving CRRT

Completed

• Conditions: Acute Kidney Failure

• Registration Number: NCT02486614
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of parameters of coagulability during Continuous Renal Replacement Therapy (CRRT) with citrate anticoagulation	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

Secondary Outcome Measures

Name	Time	Method
Determination of baseline coagulation status before initiation of citrate-based CRRT	Before initiation of 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

Trial Locations

Locations (1)

Guy's & St Thomas Hospital; 🇬🇧 London, United Kingdom