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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
Sponsor:
Information provided by (Responsible Party):
Han Chen, Fujian Provincial Hospital

Study Description
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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.


Condition or disease
Renal Injury Regional Citrate Anticoagulation Continuous Renal Replacement Therapy

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
CVVHD
Continuous Veno-Venous Hemosdialysis
CVVH
Continuous Veno-Venous Hemofiltration


Outcome Measures
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Primary Outcome Measures :
  1. Post-filter iCa [ Time Frame: 2 hours after the initiation of CRRT ]
    The post-filter ionized calcium concentration

  2. Serum iCa [ Time Frame: 2 hours after the initiation of CRRT ]
    Serum ionized calcium concentration

  3. Serum Ca2+ [ Time Frame: 2 hours after the initiation of CRRT ]
    Serum total calcium concentration

  4. Effluent Ca2+ [ Time Frame: 2 hours after the initiation of CRRT ]
    Effluent total calcium concentration


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Study Population
All patients admitted to the ICU who need RCA-CRRT will be screened for study 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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China, Fujian
Fujian Provincial Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Fa-Yang Lian, M.D.    +86 591 88216023    flsykyk@163.com   
Sponsors and Collaborators
Fujian Provincial Hospital
Investigators
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Principal Investigator: Han Chen, Ph.D., M.D. Fujian Provincial Hospital
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Chen, Fujian Provincial Hospital:
Renal Injury
Regional citrate anticoagulation
Continuous renal replacement therapy