跳至主要内容
临床试验/NCT01587963
NCT01587963终止2 期

The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
11
试验地点
1
主要终点
Efficacy of High Dose Vitamin C Therapy in Shock Patients

研究概览

简要总结

The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

详细描述

It has been shown that the stress that occurs during trauma, infection and/or shock depletes many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to further complications. The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Activation of the Mass Transfusion Protocol following surgery or trauma.
  • Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension (i.e. systolic blood pressure <90mmHg or drop of systolic blood pressure >40mmHg in the presence of infection) that does not respond to a 2 liter fluid bolus.

排除标准

  • Age less than 18 years.
  • Pregnant women.
  • Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney or end stage renal disease, rise in creatinine > 1 g/dl within 24 hours prior to enrollment.
  • Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive care unit
  • Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate dehydrogenase deficiency, Sickle Cell Disease and Thalassemia.
  • Patients in isolated cardiogenic shock.
  • History of liver cirrhosis
  • Transplant patients (liver, kidney, heart)

研究组 & 干预措施

Ascorbic Acid

Active Comparator

Ascorbic Acid

干预措施: Ascorbic Acid (Drug)

Ringers Lactate or Normal Saline

Placebo Comparator

Ringers Lactate or Normal Saline

干预措施: Ringers Lactate or Normal Saline (Other)

结局指标

主要结局

Efficacy of High Dose Vitamin C Therapy in Shock Patients

时间窗: 30 days

Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

High Dose Vitamin C in the Critically Ill Patient | 临床试验