Condition category
Not Applicable
Date applied
26/08/2008
Date assigned
04/12/2008
Last edited
30/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stanislao Morgera

ORCID ID

Contact details

Universitätskrankenhaus Charité
Medizinische Klinik - Nephrologie
Berlin
10117
Germany

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 measures

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

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

http://www.fmc-ag.com

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

Results - basic reporting

Publication summary

2011 results in: http://www.ccforum.com/content/15/S1/P127
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26415638

Publication citations

Additional files

Editorial Notes