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Recruiting NCT06021080

NCT06021080 Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions

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Clinical Trial Summary
NCT ID NCT06021080
Status Recruiting
Phase
Sponsor Fujian Provincial Hospital
Condition Renal Injury
Study Type OBSERVATIONAL
Enrollment 30 participants
Start Date 2023-10-09
Primary Completion 2026-06-09

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 100 Years
Study Type OBSERVATIONAL
Interventions
CVVHCVVHD

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 30 participants in total. It began in 2023-10-09 with a primary completion date of 2026-06-09.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

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

✉ hanchen.cn@icloud.com

📞 +86 591 88217010

Principal Investigator

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

PRINCIPAL INVESTIGATOR

Fujian Provincial Hospital

Frequently Asked Questions

Who can join the NCT06021080 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Renal Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06021080 currently recruiting?

Yes, NCT06021080 is actively recruiting participants. Contact the research team at hanchen.cn@icloud.com for enrollment information.

Where is the NCT06021080 trial being conducted?

This trial is being conducted at Fuzhou, China.

Who is sponsoring the NCT06021080 clinical trial?

NCT06021080 is sponsored by Fujian Provincial Hospital. The principal investigator is Han Chen, Ph.D., M.D. at Fujian Provincial Hospital. The trial plans to enroll 30 participants.

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