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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Han Chen, Ph.D., M.D.; Phone Number: +86 591 88217010; Email: hanchen.cn@icloud.com
• Study Contact Backup: Name: Wan-Li Yan, M.D.; Phone Number: +86 591 88217011; Email: 1727731759@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Fa-Yang Lian, M.D.; Phone Number: +86 591 88216023; Email: flsykyk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CVVHD; Continuous Veno-Venous Hemosdialysis
CVVH; Continuous Veno-Venous Hemofiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Investigators: Principal Investigator: Han Chen, Ph.D., M.D., Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): June 9, 2024
• Study Completion (Estimated): December 9, 2024

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: August 26, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Continuous renal replacement therapy; Regional citrate anticoagulation; Renal Injury
• Other Study ID Numbers: HChen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No