Pharmacokinetics of Two Different High-dose Regimens of Intravenous Vitamin C in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vitamin C plasma concentration
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetic properties of two different dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with life-threatening illness.
详细描述
Rationale:
Critically ill patients with trauma or sepsis exhibit a high degree of vitamin C deficiency at ICU admission and vitamin C plasma concentrations decrease even more during the first three days of admission. Vitamin C is a natural anti-oxidant and crucial for endothelial and organ protection
Objective:
To determine the pharmacokinetics of two high dose regimens of intravenous vitamin C in critically ill patients, in particular the attained plasma concentration and the fraction retained in the body and excreted in urine.
Study design:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sepsis or Systemic Inflammatory Response Syndrome (SIRS) after major surgery or trauma;
- •Non-neurological sequential organ failure assessment (SOFA) score >6;
- •Expected length of ICU stay > 96 hours;
- •Written proxy consent by legal representative.
排除标准
- •Admission after out of hospital cardiac arrest
- •Prior use of supplemental vitamin C in the week before
- •Major bleeding
- •Pre-existent renal insufficiency defined as an eGFR of < 30 ml/min/1.73 m2 (stadium 4-5)
- •Expected need for renal replacement therapy within 48 hours
- •Known glucose 6-phosphate dehydrogenase deficiency
- •History of urolithiasis or oxalate nephropathy
- •Previous use of prolonged high dose vitamin C supplements
- •Hemochromatosis
研究组 & 干预措施
4x 1 gram bolus (q12H) dosage regimen
1 gram of intravenous Vitamin C (ascorbic acid) is given 4 times at 12 hour intervals (total dose 4 grams).
干预措施: Ascorbic Acid (Drug)
4x 5 grams bolus (q12H) dosage regimen
5 grams of intravenous Vitamin C (ascorbic acid) is given 4 times at 12 hour intervals (total dose 20 grams).
干预措施: Ascorbic Acid (Drug)
4 gram continuous dosage regimen
1 gram per 12 hours of intravenous Vitamin C (ascorbic acid) is given continuously for 48 hours
干预措施: Ascorbic Acid (Drug)
20 gram continuous dosage regimen
5 gram per 12 hours of intravenous Vitamin C (ascorbic acid) is given continuously for 48 hours
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Vitamin C plasma concentration
时间窗: Baseline (before intervention), thereafter at 1, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours after first intervention
Vitamin C excreted in urine
时间窗: 0-12hours after first intervention; 36-48 hours after first intervention
次要结局
- Oxalate excretion in urine(0-12hours after first intervention; 36-48 hours after first intervention)
- F2-isoprostanes (oxidative damage biomarker)(0, 24 and 72 hours after first intervention)
- CellROX (reactive oxygen species activity in leukocytes)(0 and 24 hours after first intervention)
- Vasopressor requirements (noradrenalin dose)(0, 12, 24, 48, 72 and 96 hours after first intervention)
- Renal resistive index (ultrasonography)(0, 4, 24, 72 hours after first intervention)
- Serum creatinine and creatinine clearance(0, 24, 48, 72, 95 after first intervention)
- Sequential Organ Failure Assessment (SOFA) score(0, 24, 48, 72, 95 after first intervention)
研究者
H.M. Oudemans-van Straaten, MD, PhD
Intensivist
Amsterdam UMC, location VUmc