Clinical trial NCT02486614: Effect of Citrate on the Coagulation System in Patients Receiving CRRT
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Failure
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults with acute kidney injury requiring citrate based continuous renal replacement therapy

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Changes of parameters of coagulability during Continuous Renal Replacement Therapy (CRRT) with citrate anticoagulation
timeFrame: 72 hours
Secondary outcomes:
measure: Determination of baseline coagulation status before initiation of citrate-based CRRT
timeFrame: Before initiation of CRRT
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas Hospital
Study officials:
affiliation: Guy's & St Thomas' Foundation Hospital
name: Marlies Ostermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.