Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions

NCT ID: NCT06021080

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-09

Study Completion Date

2026-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It is unclear whether different modes of continuous renal replacement therapy (CRRT) impact post-filter ionized calcium concentrations during regional citrate anticoagulation (RCA) when using calcium-containing replacement fluid.

This prospective, single-center, observational cohort study will screen all patients receiving CRRT for eligibility. General clinical information will be collected before commencing CRRT treatment. Patients will be randomly assigned to either the veno-venous hemofiltration (CVVH) or continuous veno-venous hemodialysis (CVVHD) group and switch to the alternative mode in the subsequent treatment session. Pre-filter and post-filter ionized calcium, systemic total and ionized calcium, and effluent total and ionized calcium will be measured 2 hours after the initiation of CRRT. Electrolyte levels, arterial blood gases, hourly citrate dose, and total citrate dose will be recorded every 6 hours until the end of CRRT. The primary outcome is the difference in ionized calcium concentrations at each site over time between the two modes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Injury Regional Citrate Anticoagulation Continuous Renal Replacement Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CVVHD

Continuous Veno-Venous Hemosdialysis

CVVHD

Intervention Type PROCEDURE

CVVHD therapy

CVVH

Continuous Veno-Venous Hemofiltration

CVVH

Intervention Type PROCEDURE

CVVH therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CVVH

CVVH therapy

Intervention Type PROCEDURE

CVVHD

CVVHD therapy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years old;
2. Receiving citrate anticoagulation;
3. Obtain Informed consent from patients or next of kin.

Exclusion Criteria

1. Pregnant or lactating women;
2. Allergic to citrate anticoagulants;
3. Severe liver dysfunction (total bilirubin levels exceeding two times the normal range);
4. Hypoxemia (PaO2 \< 60 mmHg);
5. Inadequate tissue perfusion (blood pressure \< 90/60 mmHg despite high doses of vasoactive agents);
6. Hyperlactatemia (lactate\> 4 mmol/L);
7. Hypernatremia;
8. Estimated length of hospital stay \< 48h;
9. Participated in other studies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fujian Provincial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Han Chen

Deputy chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Han Chen, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Fujian Provincial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Han Chen, Ph.D., M.D.

Role: CONTACT

+86 591 88217010

Wan-Li Yan, M.D.

Role: CONTACT

+86 591 88217011

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fa-Yang Lian, M.D.

Role: primary

+86 591 88216023

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HChen

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.