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临床试验/NCT04792424
NCT04792424已完成不适用

No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Filter lifetime in hours

研究概览

简要总结

Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial

详细描述

Regional citrate anticoagulation is the gold standard of anticoagulation in patient receiving CRRT. In RCA circuit, there was a monitoring of pre-filter (systemic) ionized calcium and post-filter (circuit) ionized calcium. Pre-filter ionized calcium was monitored for observe the adverse effect of citrate such as hypocalcemia, citrate intoxication. However, post-filter ionized calcium was monitored for adjustment the citrate dose. We find many problem with frequently monitoring of post-ionized calcium such as confusion from markedly abnormal result, how to adjustment the citrate dose ,and increase workload for nurses. We hypothesis that if we can monitoring of post-filter ionized calcium?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

Masking of post-filter ionized calcium result in no-monitoring arm

入排标准

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

入选标准

  • Age older than 18 years old and admission in an ICU
  • Indication for CRRT
  • regional citrate anticoagulation

排除标准

  • Acute liver failure defined as AST or ALT > 5X UNL or TB/DB > 5X UNL or evidence of cirrhosis
  • Severe persistent lactic acidosis (lactate persist > 8 mg/dL consecutively within 6 hours)
  • Receiving heparin anticoagulation
  • Severe alkalosis (pH>7.55) or acidosis (pH<7.1)
  • History of renal allograft
  • Known pregnancy
  • Patient is moribund with expected death within 24 hr
  • Deficiency of ionzed calcium (Cation < 0.8 mmol/L)

研究组 & 干预措施

No monitoring of post filter ionized calcium

Experimental

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Regional citrate anticoagulation (Other)

No monitoring of post filter ionized calcium

Experimental

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Vasopressor (Drug)

No monitoring of post filter ionized calcium

Experimental

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Antibiotic (Drug)

No monitoring of post filter ionized calcium

Experimental

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Dialysis with continuous renal replacement therapy (Device)

Monitoring of post filter ionized calcium

Placebo Comparator

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Regional citrate anticoagulation (Other)

Monitoring of post filter ionized calcium

Placebo Comparator

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Vasopressor (Drug)

Monitoring of post filter ionized calcium

Placebo Comparator

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Antibiotic (Drug)

Monitoring of post filter ionized calcium

Placebo Comparator

Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.

Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.

Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L.

Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

干预措施: Dialysis with continuous renal replacement therapy (Device)

结局指标

主要结局

Filter lifetime in hours

时间窗: 72 hours

How long with filter with RCA

次要结局

  • Adverse event(72 hours)
  • Circuit downtime in hours(72 hours)
  • Cost per treatment in Baht(72 hour)
  • Citrate accumulation(72 hours)
  • Efficacy of CRRT(72 hours)
  • Citrate dose(72 hours)

研究者

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

Nattachai Srisawat ,M.D.

Director of Excellence Center for Critical Care Nephrology

Chulalongkorn University

研究点 (1)

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