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NCT Number: NCT06021080

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

CVVH

Procedure

CVVH therapy

CVVHD

Procedure

CVVHD therapy

Primary outcomes

  1. Post-filter iCa

    Time frame: 2 hours after the initiation of CRRT

    The post-filter ionized calcium concentration

  2. Serum iCa

    Time frame: 2 hours after the initiation of CRRT

    Serum ionized calcium concentration

  3. Serum Ca2+

    Time frame: 2 hours after the initiation of CRRT

    Serum total calcium concentration

  4. Effluent Ca2+

    Time frame: 2 hours after the initiation of CRRT

    Effluent total calcium concentration

Secondary outcomes

  1. Incidence of new-onset metabolic complications

    Time frame: 48 hours after the initiation of CRRT

    Including hypercalcemia, hypocalcemia, metabolic acidosis, metabolic alkalosis, citrate accumulation, hypernatremia, and hyponatremia

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+86 591 88217010

Wan-Li Yan, M.D.

CONTACT

[email protected]

+86 591 88217011

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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