Clinical trial NCT06021080: Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions
Official title: Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Injury
Regional Citrate Anticoagulation
Continuous Renal Replacement Therapy
Keywords: Renal Injury
Regional citrate anticoagulation
Continuous renal replacement therapy
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU who need RCA-CRRT will be screened for study eligibility.

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.

Primary outcomes:
measure: Post-filter iCa
timeFrame: 2 hours after the initiation of CRRT
measure: Serum iCa
timeFrame: 2 hours after the initiation of CRRT
measure: Serum Ca2+
timeFrame: 2 hours after the initiation of CRRT
measure: Effluent Ca2+
timeFrame: 2 hours after the initiation of CRRT
Secondary outcomes:
measure: Incidence of new-onset metabolic complications
timeFrame: 48 hours after the initiation of CRRT
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Han Chen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: