Safety of Regional Citrate Anticoagulation Delivered by the Multifiltratepro System in Continuous Renal Replacement Therapy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-010938
Sponsor Protocol Number: Ci-Ca-001
About this study
The purpose of this study is to demonstrate the safety of Regional Citrate Anticoagulation (RCA) in adult patients requiring Continuous Renal Replacement Therapy (CRRT.)
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Signed informed consent from by
- The subject; or
- The LAR, if the subject is unable to consent.
- Adult patients ≥ 18 years old.
- Diagnosis of AKI or ESKD requiring CRRT.
- Vascular access – Dialysis Catheter with size and location per institutional practice.
Exclusion Criteria:
- 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 INR greater than 2.0 and total bilirubin greater than 5 mg/dL, and both AST and 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.
- Previous participation in a similar or the same study.
- Subjects already on continuous renal replacement therapy.
- Subjects with active COVID-19 infection.
- Subject cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/22/24. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Dillon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available