Renal InjuryNCT06021080
Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions
An observational study of Renal Injury and Regional Citrate Anticoagulation, run by Fujian Provincial Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Renal Injury, Regional Citrate Anticoagulation, Continuous Renal Replacement Therapy
- What is being tested?
- CVVH and CVVHD
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 9 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the ICU who need RCA-CRRT will be screened for study eligibility.
Who may be able to join
- Age ≥ 18 years old;
- Receiving citrate anticoagulation;
- Obtain Informed consent from patients or next of kin.
Who cannot join
- 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);
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- Hypernatremia;
- Estimated length of hospital stay < 48h;
- Participated in other studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Fa-Yang Lian, M.D., +86 591 88216023, flsykyk@163.com
About this study
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.
- Being tested
- CVVH, CVVHD
- Keywords
- Renal Injury, Regional citrate anticoagulation, Continuous renal replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVHProcedure or surgery
CVVH therapy
CVVHDProcedure or surgery
CVVHD therapy
| Study group | Role | What they receive |
|---|---|---|
| CVVHD | Continuous Veno-Venous Hemosdialysis Receives: Procedure: CVVHD | |
| CVVH | Continuous Veno-Venous Hemofiltration Receives: Procedure: CVVH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-filter iCa
The post-filter ionized calcium concentration
Measured: 2 hours after the initiation of CRRT
Serum iCa
Serum ionized calcium concentration
Measured: 2 hours after the initiation of CRRT
Serum Ca2+
Serum total calcium concentration
Measured: 2 hours after the initiation of CRRT
Effluent Ca2+
Effluent total calcium concentration
Measured: 2 hours after the initiation of CRRT
Secondary outcomes (1)
Incidence of new-onset metabolic complications
Including hypercalcemia, hypocalcemia, metabolic acidosis, metabolic alkalosis, citrate accumulation, hypernatremia, and hyponatremia
Measured: 48 hours after the initiation of CRRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start9 Oct 2023
- Primary completion9 Jun 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Chen, Fujian Provincial Hospital
- Investigators
- Han Chen, Ph.D., M.D., Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021080
- Sponsor's protocol ID
- HChen
- Status last verified
- Mar 2025
- First submitted
- 26 Aug 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions
- ClinicalTrials.gov ID
- NCT06021080
- Acronym / sponsor ID
- HChen
- Keywords
- Renal Injury, Regional citrate anticoagulation, Continuous renal replacement therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 9 Jun 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVVHD | – | Procedure: CVVHDContinuous Veno-Venous Hemosdialysis |
| CVVH | – | Procedure: CVVHContinuous Veno-Venous Hemofiltration |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU who need RCA-CRRT will be screened for study eligibility.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old;
- Receiving citrate anticoagulation;
- Obtain Informed consent from patients or next of kin.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVVHCVVH therapy | Procedure or surgery | CVVH |
| CVVHDCVVHD therapy | Procedure or surgery | CVVHD |
Primary outcome
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
1 secondary outcome
Incidence of new-onset metabolic complications
Time frame: 48 hours after the initiation of CRRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Han Chen, Ph.D., M.D. principal investigator
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Injury and Regional Citrate Anticoagulation, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han Chen, Ph.D., M.D. (+86 591 88217010, hanchen.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-filter iCa (time frame: 2 hours after the initiation of CRRT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.