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Prospective, multicenter, randomized controlled, and non-inferiority clinical trial of region citrate anticoagulant infusion system during blood purification

Prospective, multicenter, randomized controlled, and non-inferiority clinical trial of region citrate anticoagulant infusion system during blood purification

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074083
Enrollment
Unknown
Registered
2023-07-28
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

renal failure

Interventions

1:Using a region citrate anticoagulant infusion system to assist in anticoagulant infusion
2:Using the Fresenius Ci-Ca method to guide infusion pumps and injection pumps to assist anticoagulant infusion

Sponsors

shanghai ruijin hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old = age = 80 years old, regardless of gender; (2) Diagnosed as acute or chronic renal failure, renal replacement therapy is required, and the researcher has determined that CRRT treatment is recommended; (3) Researchers determine that patients can establish stable vascular pathways; (4) The subjects and their guardians are able to understand the research purpose and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Drugs or preparations containing citric acid have been used within 72 hours, and blood transfusion treatment is expected to be required in clinical trials; (2) During the CRRT process, calcium supplementation therapy that is not required by the protocol is required; (3) Unable to establish a stable blood flow pathway for blood vessels (the pathway can provide a constant and effective blood flow greater than 200ml/min): (4) Previous allergies to extracorporeal circulation pipelines, blood purification equipment, blood exchange fluids, dialysate, citric acid, calcium containing solutions, etc; (5) Unable to tolerate CRRT treatment; (6) During the experiment, peritoneal dialysis needs to be used simultaneously; (7) Those with an ion calcium concentration in the body less than 0.95 or greater than 1.35 mmol/L; (8) Has participated or is currently participating in other clinical trials within 3 months from the date of signing the informed consent form; (9) Pregnant and lactating women; (10) Patients with active malignant tumors; (11) Expected survival time is less than 72 hours; (12) Other situations where the researcher determines that it is not suitable to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Ionized calcium;

Secondary

MeasureTime frame
the accuracy of citrate pump ;the accuracy of calcium pump ;

Countries

China

Contacts

Public ContactChen Xiaonong

shanghai ruijin hospital

cxn10419@rjh.com.cn+86 21 3418 6000

Outcome results

None listed

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