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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Dialysis
Combination productIn this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Ci-Ca ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Symptoms and systemic ionized calcium level
Defined as a symptomatic episode of delirium, coma, nausea, vomiting, constipation, muscle weakness, hypertension, bradycardia, deemed attributable to hypercalcemia with a confirmed systemic ionized calcium \> 1.5mmol/L.
Time frame
Up to 1 month2
Arterial pH measure and bicarbonate level
Arterial pH \> 7.55 and bicarbonate \> 30 mmol/L in the absence of exogenous bicarbonate administered
Time frame
Up to 1 month3
Serum sodium (Na) level
Serum sodium (Na) level \> 150 mmol/L and \> 5 mmol/L rise in systemic Na above the prescribed CRRT fluids. Na level in the absence of hypertonic intravenous Na infusion
Time frame
Up to 1 month4
Drop in hemoglobin (Hgb)
Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion
Time frame
Up to 1 monthSecondary outcomes
1
Circuit life
Circuit life is defined by time to circuit replacement
Time frame
The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.Other outcomes
1
Adverse Events
Adverse Events
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov