SAfety of Regional Citrate Anticoagulation (SARCA Study)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFresenius Medical Care North America
About this trial
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).
Eligibility criteria
Qualifiers
Signed informed consent form by
The subject or
A legally authorized representative (LAR), if the subject is unable to consent
Adult patients ≥ 18 years old
Disqualifiers
Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
A female who is pregnant or breast feeding
Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal
Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
Trial design
Treatments tested in this trial
- Dialysis
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov