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临床试验/NCT06021080
NCT06021080招募中不适用

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

Fujian Provincial Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Post-filter iCa

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old;
  • Receiving citrate anticoagulation;
  • Obtain Informed consent from patients or next of kin.

排除标准

  • 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.

结局指标

主要结局

Post-filter iCa

时间窗: 2 hours after the initiation of CRRT

The post-filter ionized calcium concentration

Serum iCa

时间窗: 2 hours after the initiation of CRRT

Serum ionized calcium concentration

Serum Ca2+

时间窗: 2 hours after the initiation of CRRT

Serum total calcium concentration

Effluent Ca2+

时间窗: 2 hours after the initiation of CRRT

Effluent total calcium concentration

次要结局

  • Incidence of new-onset metabolic complications(48 hours after the initiation of CRRT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Han Chen

Deputy chief physician

Fujian Provincial Hospital

研究点 (1)

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