BridgeMD
Tests treatment safety and results for Acute Kidney Injury
Official title SAfety of Regional Citrate Anticoagulation (SARCA Study)
ClinicalTrials.gov ID: NCT05339139
What this study is testing
What is Dialysis?
Dialysis is an investigational medicine, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
You likely can't join if
- 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...
- people currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed...
- Previous participation in a similar or the same study.
- people already on continuous renal replacement therapy
See the full eligibility criteria
- 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
- Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
- Vascular access - Dialysis Catheter with size and location per institutional practice
- 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...
- people 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.
- people already on continuous renal replacement therapy
- people with active COVID-19 infection
- people cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Orlando, Florida, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Jackson, Mississippi, United States
- St Louis, Missouri, United States
- Murray, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Orlando, Florida, United States; Worcester, Massachusetts, United States; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.