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A randomized, open-label, parallel-controlled, single-center, phase II clinical trial of the efficacy and safety of phosphate hemofiltrate replacement solution in continuous renal replacement therapy

A randomized, open-label, parallel-controlled, single-center, phase II clinical trial of the efficacy and safety of phosphate hemofiltrate replacement solution in continuous renal replacement therapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080645
Enrollment
Unknown
Registered
2024-02-04
Start date
2024-02-08
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Continuous Renal Replacement Therapy

Interventions

The test groups:Phosphrate Hemofiltration Replacement Solution
The control group:Hemofiltration basic solution

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in this study. 1) Age 18-70 years old (including 18 years old and 70 years old), gender is not limited; 2) Meet the CRRT indications in the Standard Operating Procedures for Blood Purification (2021 Edition) and have been assessed by a qualified nephrology or critical care physician to require CRRT treatment; 3) Planned continuous blood purification time= 48 hours; 4) Patients or their guardians have a full understanding of the purpose and significance of this trial, voluntarily participate in this study and follow the study procedures, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Subjects who meet any of the following criteria will not be allowed to participate in this study. 1) Those who are known to be allergic to any component of the test drug, or those who are allergic; 2) inability to establish suitable vascular access; 3) with refractory hypotension (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg); 4) Have malignant tumors with or without systemic metastases; 5) Combined with thromboembolic disease; 6) Pregnant and lactating females; 7) Patients who have received CRRT treatment within 72 hours before screening; 8) Those who have used other experimental drugs or devices within 1 month before screening, or participated in other clinical trials at the same time; 9) Patients who, in the opinion of the investigator, are not suitable to participate in this study due to other reasons.

Design outcomes

Primary

MeasureTime frame
Incidence of hypophosphatemia within 48 hours;

Secondary

MeasureTime frame
Incidence of hypophosphatemia within 24 hours;Frequency of hypophosphatemia within 24 hours and 48 hours;Frequency and amount of phosphorus supplementation;Incidence of hyperglycemia;Insulin usage;Degree of change from baseline in serum creatinine;Sequential Organ Failure Score (SOFA);

Countries

China

Contacts

Public ContactLing.Zhang / Ping.Feng

West China Hospital of Sichuan University

zhanglinglzy@163.com+86 189 8060 1985

Outcome results

None listed

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