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临床试验/EUCTR2020-001276-15-FR
EUCTR2020-001276-15-FR进行中(未招募)1 期

Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study. - VITAKI

CHU Amiens-Picardie0 个研究点目标入组 310 人开始时间: 2020年4月21日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
310

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP =65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 210
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Presence of inclusion criteria for more than 24 hours
  • Immediate indication to start renal replacement therapy at the time of randomization: Hyperkalemia= 6.5 mmol /l, metabolic acidosis with pH <7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis.
  • Formal indication of Nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism)
  • Known severe chronic kidney disease (clearance <30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient.
  • Moribund patient (estimated survival less than 24 hours)
  • Patient who are not expected to survive to day 30 due to terminal-stage disease (terminal respiratory or heart failure, Child C cirrhosis, uncontrolled cancer)
  • Resuscitated cardiac arrest

研究者

发起方
CHU Amiens-Picardie

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