Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CVVHD- Ci-Ca-01-EU
Study information
Scientific title
Citrate anticoagulation during continuous veno-venous haemodialysis (CVVHD) - an observational study
Acronym
LCAT study
Study hypothesis
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
Ethics Committee of Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), 27/07/2007, ref: EA1/101/07
Study design
Prospective observational open multi-centre study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
07/12/2007
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
07/12/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Austria, Germany, Norway, Switzerland, United Kingdom
Trial participating centre
Universitätskrankenhaus Charité
Berlin
10117
Germany
Sponsor information
Organisation
Fresenius Medical Care (Germany)
Sponsor details
Else-Kröner-Str. 1
Bad Homburg
61352
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fresenius Medical Care (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ccforum.com/content/15/S1/P127
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26415638