ACTRN12619000909123招募中2 期
Vitamin C for prevention of acute kidney injury in high-risk critically ill patients: a pilot randomized controlled trial study
Professor Rinaldo Bellomo0 个研究点目标入组 50 人开始时间: 2019年6月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Within first 24 hours of intensive care unit admission
- •NephroCheck urine test positive result which is defined as a value exceeding more than 2 ng per ml / 1000.
- •No evidence of acute kidney dysfunction on intensive care unit admission defined as a serum creatinine measured being less than 150 mircomol/L
- •No chronic kidney disease defined by the stage II or greater using the Kidney Disease Improving Global Outcomes classification
- •Are expected to stay in the ICU at least until the day after tomorrow.
- •Use of indwelling urinary catheter as standard care expected for at least 72 hours after enrolment
- •At least one of the following acute conditions within 24 hours prior to enrolment, which define clinical high-risk of AKI
- •Respiratory Sequential Organ Failure Assessment (SOFA) score of equal to or greater than 2 (PaO2/FiO2 < 300)
- •Cardiovascular SOFA score of equal to or greater than 1 (Mean arterial pressure less than 70 mmHg and/or any vasopressor required)
排除标准
- •DNR (do not resuscitate) DNI (do not intubate) orders
- •Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment
- •Already receiving dialysis (either acute or chronic) or imminent need of dialysis at the time of enrolment
- •Known moderate to severe AKI prior to enrolment (KDIGO stage II or greater)
- •Receiving kidney transplantation
- •Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with patient's participation in this study
- •Patients with known HIV infection
- •Patients with known or suspected history of oxalate nephropathy or hyperoxaluria, scurvy, chronic iron overload, G-6PD deficiency
- •Clinician expects to prescribe high dose vitamin C for another indications
- •Patients with known haemochromatosis.
研究者
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