iver Citrate Anticoagulation Threshold study
Not Applicable
Completed
- Conditions
- Intensive care patients with renal failureNot Applicable
- Registration Number
- ISRCTN92716512
- Lead Sponsor
- Fresenius Medical Care (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main end-points for the safety evaluation is the occurrence of citrate metabolic complications (hypocalcemia, hypercalcemia, alkalosis, acidosis). <br><br>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
Name Time Method o secondary outcome measures