Safety of Regional Citrate Anticoagulation for Kidney Injury
This study, called SARCA, is looking at the safety of a specific type of dialysis called Regional Citrate Anticoagulation (RCA) delivered by the multiFiltratePRO system. RCA is used during Continuous Renal Replacement Therapy (CRRT), a treatment for kidney failure, to prevent blood clots in the dialysis machine. This approach might reduce bleeding risks compared to standard treatments. The study aims to enroll 50 adults who have acute kidney injury (AKI) or end-stage kidney disease (ESKD) and need CRRT. Researchers will be looking at your symptoms, calcium levels, blood pH, bicarbonate, and sodium levels for up to one month to see how safe and effective this treatment is. The current recruitment status is unclear.
- Study design
- This is an open-label, prospective study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 50 adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms and blood levels will be monitored for up to one month after starting the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SAfety of Regional Citrate Anticoagulation (SARCA Study)
At a glance
Conditions
Where it's being run
10 sites across 8 statesStudy leadership
- Manuela Stauss-Grabo, PhD · STUDY_DIRECTOR · Fresenius Medical Care North America
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Symptoms and systemic ionized calcium levelUp to 1 month
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.
- Arterial pH measure and bicarbonate levelUp to 1 month
Arterial pH \> 7.55 and bicarbonate \> 30 mmol/L in the absence of exogenous bicarbonate administered
- Serum sodium (Na) levelUp to 1 month
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
- Drop in hemoglobin (Hgb)Up to 1 month
Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion
- Symptoms and systemic ionized calcium levelUp to 1 month
defined as a symptomatic episode of tetany/spasms, seizures, deemed attributable to hypocalcemia and with a confirmed systemic iCa \< 0.85 mmol/L.
- Symptoms and total-to-ionized calcium ratioUp to 1 month
Patients with impaired citrate metabolism or citrate overdose can exhibit citrate accumulation. Symptomatic citrate accumulation presents with symptoms of tetany/spasms, seizures, systemic hypocoagulability, hypotension, or cardiac events; and should be confirmed with: 1. A total-to-ionized calcium ratio \> 2.5; OR 2. A total-to-ionized calcium ratio greater than 2.25 together with one or more of the following criteria: 1. an increase in calcium supplementation, 2. decreasing systemic ionized calcium, and 3. metabolic acidosis. When a clinical presentation is possibly associated with an abnormal concentration of systemic ionized calcium or an altered acid-base balance, the labs ({Calcium: systemic ionized calcium, post-filter ionized calcium and total calcium}, bicarbonate, sodium, potassium, magnesium, phosphate) should be checked immediately.