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Recruiting NCT05339139

SAfety of Regional Citrate Anticoagulation (SARCA Study)

Phase III Interventional Acute Kidney Injury ESRD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dialysis.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, ESRD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

Detailed description

In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding.

An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.

The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.

Interventions

  • Combination product Dialysis
    In 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.

Primary outcome measures

  • Symptoms and systemic ionized calcium level [Time frame: Up to 1 month]
  • Arterial pH measure and bicarbonate level [Time frame: Up to 1 month]
  • Serum sodium (Na) level [Time frame: Up to 1 month]
  • Drop in hemoglobin (Hgb) [Time frame: Up to 1 month]
  • Symptoms and systemic ionized calcium level [Time frame: Up to 1 month]
  • Symptoms and total-to-ionized calcium ratio [Time frame: Up to 1 month]
Secondary outcome measures (1)
  • Circuit life [Time frame: The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.]

Eligibility criteria

Inclusion 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

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 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
  • Previous participation in a similar or the same study.
  • Subjects already on continuous renal replacement therapy
  • Subjects with active COVID-19 infection
  • Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • John L. McClellan Memorial Veterans' Hospital — Little Rock
  • University of Arkansas for Medical Sciences (UAMS) — Little Rock
  • Advent Health Orlando — Orlando
  • UMass Memorial Medical Center — Worcester
  • University of Michigan — Ann Arbor
  • Henry Ford Hospital — Detroit
  • Mayo Clinic — Rochester
  • University of Mississippi Medical Center — Jackson
  • … and 2 more centers

Identifiers

NCT: NCT05339139 · Ci-Ca-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗