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

Renal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021080
• Other study ID #: HChen
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: December 9, 2024

Study information

• Verified date: September 2023
• Source: Fujian Provincial Hospital
• Contact: Han Chen, Ph.D., M.D.
• Phone: +86 591 88217010
• Email: hanchen.cn[@]icloud.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 9, 2024
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Continuous Renal Replacement Therapy
• Regional Citrate Anticoagulation
• Renal Injury

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-filter iCa	The post-filter ionized calcium concentration	2 hours after the initiation of CRRT
Primary	Serum iCa	Serum ionized calcium concentration	2 hours after the initiation of CRRT
Primary	Serum Ca2+	Serum total calcium concentration	2 hours after the initiation of CRRT
Primary	Effluent Ca2+	Effluent total calcium concentration	2 hours after the initiation of CRRT
Secondary	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