2024-517055-13-00招募中3 期
Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 12
- 主要终点
- the proportion of patients meeting one or more criteria for MAKE30: inhospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine on day 30
研究概览
简要总结
to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care
研究设计
- 分配方式
- Randomized
- 主要目的
- Vitamine PP Versus Placebo
- 盲法
- Double (Carer, Subject, Analyst, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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
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)
- •Resuscitated cardiac arrest
- •Patient admitted to intensive care for more than 5 days
结局指标
主要结局
the proportion of patients meeting one or more criteria for MAKE30: inhospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine on day 30
the proportion of patients meeting one or more criteria for MAKE30: inhospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine on day 30
次要结局
- The reduction in the incidence of moderate to severe AKI defined as stage 2 and 3 of the KDIGO 2012 classification.
- The increase in the number of days living without renal replacement therapy (censored at death or at day 30).
- Length of hospital stay: defined as the time between admission date of admission and discharge for subjects discharged alive from the resuscitation
- Reduction of the incidence of major renal adverse events at J90 (MAKE 90).The reduction of the intensive care unit length of stay.
- liver toxicity, checked on day 1, Day2, day 3 and day 7 (transaminases, bilirubin, alkaline phosphatase, gamma-glutamyltransferase), nausea, vomiting, headache, flushing, facial erythema
- Evaluate the effectiveness of Nicotinamide supplementation according to the urinary quinolonate/ tryptophan ratio on D0 and D1
研究者
TITECA BEAUPORT Dimitri
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (12)
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