RECRUITING

SAfety of Regional Citrate Anticoagulation (SARCA Study)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2023-10-17

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05339139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed informed consent form by * The subject or * A legally authorized representative (LAR), if the subject is unable to consent 2. Adult patients ≥ 18 years old 3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT 4. Vascular access - Dialysis Catheter with size and location per institutional practice	1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55 2. A female who is pregnant or breast feeding 3. 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 4. Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent 5. Previous participation in a similar or the same study. 6. Subjects already on continuous renal replacement therapy 7. Subjects with active COVID-19 infection 8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

Inclusion Criteria

Exclusion Criteria

1. Signed informed consent form by
* The subject or
* A legally authorized representative (LAR), if the subject is unable to consent
2. Adult patients ≥ 18 years old
3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
4. Vascular access - Dialysis Catheter with size and location per institutional practice

1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
2. A female who is pregnant or breast feeding
3. 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
4. Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
5. Previous participation in a similar or the same study.
6. Subjects already on continuous renal replacement therapy
7. Subjects with active COVID-19 infection
8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

Contacts and Locations

Study Contact

Neha Ghosh, PhD

CONTACT

+1 734-957-6920

neha.ghosh@freseniusmedicalcare.com

Manuela Stauss-Grabo, PhD

CONTACT

+49 1525 469 1929

manuela.stauss-grabo1@freseniusmedicalcare.com

Principal Investigator

Manuela Stauss-Grabo, PhD

STUDY_DIRECTOR

Fresenius Medical Care North America

Study Locations (Sites)

John L. McClellan Memorial Veterans' Hospital

Little Rock, Arkansas, 72205

United States

University of Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas, 72205

United States

University of Michigan

Ann Arbor, Michigan, 48109-5000

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Washington University - Hospital

Saint Louis, Missouri, 63110

United States

Intermountain Health

Murray, Utah, 84107

United States

Collaborators and Investigators

Sponsor: Fresenius Medical Care North America

Manuela Stauss-Grabo, PhD, STUDY_DIRECTOR, Fresenius Medical Care North America

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2023-10-17

Study Completion Date2025-03-30

Terms related to this study

Additional Relevant MeSH Terms

Acute Kidney Injury
ESRD