NCT06021080

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

August 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2026

Last Updated

August 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

August 26, 2023

Last Update Submit

August 5, 2025

Conditions

Renal InjuryRegional Citrate AnticoagulationContinuous Renal Replacement Therapy

Keywords

Renal InjuryRegional citrate anticoagulationContinuous renal replacement therapy

Outcome Measures

Primary Outcomes (4)

  • Post-filter iCa

    The post-filter ionized calcium concentration

    2 hours after the initiation of CRRT

  • Serum iCa

    Serum ionized calcium concentration

    2 hours after the initiation of CRRT

  • Serum Ca2+

    Serum total calcium concentration

    2 hours after the initiation of CRRT

  • Effluent Ca2+

    Effluent total calcium concentration

    2 hours after the initiation of CRRT

Secondary Outcomes (1)

  • Incidence of new-onset metabolic complications

    48 hours after the initiation of CRRT

Study Arms (2)

CVVHD

Continuous Veno-Venous Hemosdialysis

Procedure: CVVHD

CVVH

Continuous Veno-Venous Hemofiltration

Procedure: CVVH

Interventions

CVVHPROCEDURE

CVVH therapy

CVVH
CVVHDPROCEDURE

CVVHD therapy

CVVHD

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the ICU who need RCA-CRRT will be screened for study eligibility.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Interventions

Continuous Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Han Chen, Ph.D., M.D.

    Fujian Provincial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86 591 88217010hanchen.cn@icloud.com

Wan-Li Yan, M.D.

CONTACT

+86 591 882170111727731759@qq.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 1, 2023

Study Start

October 9, 2023

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

December 9, 2026

Last Updated

August 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)