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Regional citrate anticoagulation versus nafamostat mesylate for continuous renal replacement therapy in patients at high risk of bleeding: a prospective randomized study

Regional citrate anticoagulation versus nafamostat mesylate for continuous renal replacement therapy in patients at high risk of bleeding: a prospective randomized study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083973
Enrollment
Unknown
Registered
2024-05-08
Start date
2024-05-13
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who need CRRT and are at high risk for bleeding

Interventions

RAC group:4% regional citrate anticoagulation
NM group: Nafamostat Mesilate( NM)

Sponsors

Department of Nephrology, the First Affiliated Hospital, the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years old 2) CRRT treatment: (1) unmanageable volume overload associated with organ edema or drug overdoses and toxins that can be cleared by dialysis; (2) Uncorrectable acidosis (metabolic or mixed acidosis, blood pH 6.5 mmol/L; Blood sodium > 160mmol/L or blood sodium 30 mmol/L),6, others 3) High-risk bleeding patients: PLT 60 s, INR > 2.0, bleeding or active bleeding within 7 days, recent trauma or surgical procedures (especially head trauma and neurosurgery), recent stroke, intracranial venous malformations or aneurysms, retinal bleeding, uncontrolled hypertension, There's an epidural catheter implanted 4) Agree to join the study

Exclusion criteria

Exclusion criteria: 1) Patients with previous regular hemodialysis and peritoneal dialysis 2) Patients who are receiving systemic anticoagulation (heparin/low molecular weight/warfarin, etc.) and do not require additional anticoagulant use 3) Shock combined with tissue hypoperfusion: ? persistent hypotension(systolic blood pressure 40 mmHg); ? Serum lactic acid >4mmol/L; ? On the basis of sufficient replenishment of blood volume, it is still necessary to use pressor drugs to maintain the mean arterial pressure >65mmHg 4) Severe liver failure: Child-Pugh score > 10 (chronic severe liver failure), MELD score > 30 (acute severe liver failure), total bilirubin > 51µmol/L 5) Patients who are pregnant or breastfeeding 6)HIV infection 7) Contraindications to the use of sodium citrate or napalmostat mesylate (allergies, history of prior drug accumulation)

Design outcomes

Primary

MeasureTime frame
Incidence of filter failure;

Secondary

MeasureTime frame
28 day mortality rate;

Countries

China

Contacts

Public ContactMingbai

Department of Nephrology, Xijing Hospital, The Fourth Military Medical University

mingbai1983@126.com+86 137 7210 4001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026