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

Recruiting

• Conditions: Renal Injury; Regional Citrate Anticoagulation; Continuous Renal Replacement Therapy

• Registration Number: NCT06021080
• Lead Sponsor: Fujian Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-26
• Study First Posted: 2023-09-01
• Study Start: 2023-10-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-06
• Primary Completion: 2026-06-09
• Study Completion: 2026-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-filter iCa	2 hours after the initiation of CRRT	The post-filter ionized calcium concentration
Serum iCa	2 hours after the initiation of CRRT	Serum ionized calcium concentration
Serum Ca2+	2 hours after the initiation of CRRT	Serum total calcium concentration
Effluent Ca2+	2 hours after the initiation of CRRT	Effluent total calcium concentration

Secondary Outcome Measures

Name	Time	Method
Incidence of new-onset metabolic complications	48 hours after the initiation of CRRT	Including hypercalcemia, hypocalcemia, metabolic acidosis, metabolic alkalosis, citrate accumulation, hypernatremia, and hyponatremia

Trial Locations

Locations (1)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China