Liver Citrate Anticoagulation Threshold study

ISRCTN	ISRCTN92716512
DOI	https://doi.org/10.1186/ISRCTN92716512
Secondary identifying numbers	CVVHD- Ci-Ca-01-EU

Submission date: 26/08/2008
Registration date: 04/12/2008
Last edited: 30/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stanislao Morgera
Scientific

Universitätskrankenhaus Charité
Medizinische Klinik - Nephrologie
Berlin
10117
Germany

Study information

Study design	Prospective observational open multi-centre study
Primary study design	Observational
Secondary study design
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Citrate anticoagulation during continuous veno-venous haemodialysis (CVVHD) - an observational study
Study acronym	LCAT study
Study objectives	1. Assessment of the safety and efficacy of regional citrate anticoagulation during continuous veno-venous haemodialysis (CVVHD) using multiFiltrate with the Ci-Ca System® 2. Investigation of the impact of liver failure on safety, efficacy and dosing schemes of this procedure
Ethics approval(s)	Ethics Committee of Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), 27/07/2007, ref: EA1/101/07
Health condition(s) or problem(s) studied	Intensive care patients with renal failure
Intervention	Every patient will be observed for 72 hours after the start of the Ci-Ca CVVHD treatment. The participation in the study and the data collection will be terminated before 72 hours if the patient does not require a Ci-Ca CVVHD treatment any more.
Intervention type	Other
Primary outcome measure	Main end-points for the safety evaluation is the occurrence of citrate metabolic complications (hypocalcemia, hypercalcemia, alkalosis, acidosis). For the efficacy evaluation main end-points are: the percentage of functioning filters after 72 treatment hours and post-filter ionized calcium.
Secondary outcome measures	No secondary outcome measures
Overall study start date	07/12/2007
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	120
Key inclusion criteria	1. Adult patients (at least 18 years old, both males and females) treated on intensive care unit (ICU) due to renal failure requiring CVVHD and citrate anticoagulation (treatment with the multiFiltrate Ci-Ca System®) 2. Patient (or his legal representative or the next of kin - according to the local requirements) written informed consent
Key exclusion criteria	1. Use of regional citrate anticoagulation in the period of 72 hours preceding the enrolment in the study 2. Concomitant participation in another clinical trial 3. Previous participation in the same study
Date of first enrolment	07/12/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Austria
Germany
Norway
Switzerland
United Kingdom

Study participating centre

Universitätskrankenhaus Charité

Berlin
10117
Germany

Sponsor information

Fresenius Medical Care (Germany)
Industry

Else-Kröner-Str. 1
Bad Homburg
61352
Germany

Website	http://www.fmc-ag.com
"ROR"	https://ror.org/04sk0bj73

Funders

Funder type

Industry

Fresenius Medical Care (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No
Results article	results	29/09/2015		Yes	No