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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ClinicalTrials.gov Identifier: NCT06021080 |
Recruitment Status :
Recruiting
First Posted : September 1, 2023
Last Update Posted : September 21, 2023
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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.
Condition or disease |
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Renal Injury Regional Citrate Anticoagulation Continuous Renal Replacement Therapy |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 30 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Month |
Official Title: | Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions |
Actual Study Start Date : | June 9, 2023 |
Estimated Primary Completion Date : | June 9, 2024 |
Estimated Study Completion Date : | December 9, 2024 |
Group/Cohort |
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CVVHD
Continuous Veno-Venous Hemosdialysis
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CVVH
Continuous Veno-Venous Hemofiltration
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- Post-filter iCa [ Time Frame: 2 hours after the initiation of CRRT ]The post-filter ionized calcium concentration
- Serum iCa [ Time Frame: 2 hours after the initiation of CRRT ]Serum ionized calcium concentration
- Serum Ca2+ [ Time Frame: 2 hours after the initiation of CRRT ]Serum total calcium concentration
- Effluent Ca2+ [ Time Frame: 2 hours after the initiation of CRRT ]Effluent total calcium concentration
- 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
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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021080
Contact: Han Chen, Ph.D., M.D. | +86 591 88217010 | hanchen.cn@icloud.com | |
Contact: Wan-Li Yan, M.D. | +86 591 88217011 | 1727731759@qq.com |
China, Fujian | |
Fujian Provincial Hospital | Recruiting |
Fuzhou, Fujian, China, 350001 | |
Contact: Fa-Yang Lian, M.D. +86 591 88216023 flsykyk@163.com |
Principal Investigator: | Han Chen, Ph.D., M.D. | Fujian Provincial Hospital |
Responsible Party: | Han Chen, Deputy chief physician, Fujian Provincial Hospital |
ClinicalTrials.gov Identifier: | NCT06021080 |
Other Study ID Numbers: |
HChen |
First Posted: | September 1, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Renal Injury Regional citrate anticoagulation Continuous renal replacement therapy |