Liver Citrate Anticoagulation Threshold study
| ISRCTN | ISRCTN92716512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92716512 |
| Protocol serial number | CVVHD- Ci-Ca-01-EU |
| Sponsor | Fresenius Medical Care (Germany) |
| Funder | Fresenius Medical Care (Germany) |
- 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
Scientific
Universitätskrankenhaus Charité
Medizinische Klinik - Nephrologie
Berlin
10117
Germany
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational open multi-centre study |
| Secondary study design | |
| Study type | Participant 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(s) |
Main end-points for the safety evaluation is the occurrence of citrate metabolic complications (hypocalcemia, hypercalcemia, alkalosis, acidosis). |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Austria
- Germany
- Norway
- Switzerland
Study participating centre
Universitätskrankenhaus Charité
Berlin
10117
Germany
10117
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
