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临床试验/NCT00497978
NCT00497978已完成不适用

The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient

Medical Center Alkmaar2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2008年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
2
主要终点
morbidity and mortality

研究概览

简要总结

The purpose of this study is to reduce the postoperative morbidity and mortality in the elderly hip fracture patient, by giving them taurine peri-operatively.

详细描述

Rationale: A growing medical concern is the increase in the number of very old patients, especially the patients undergoing hip fracture surgery are rapidly increasing in numbers. Hip surgery in these old patients induces serious morbidity and gives rise to excessive mortality rates. Studies with perioperative nutritional interventions performed within this population have shown improved clinical outcome, but were not well controlled and lack insight in the working mechanism. Therefore nutritional intervention studies are needed using a single nutrient. In trauma patients for instance it is known that the administration of glutamine (as a single amino acid) reduces morbidity, which is probably related to its antioxidant properties; reducing oxidative stress and insulin resistance. As an antioxidant the amino acid taurine has even greater potential providing benefit in several groups of patients. Elderly hip fracture patients have very low plasma levels of antioxidants which make them highly vulnerable for oxidative stress and related insulin resistance.In elderly patients with a hip fracture, it is hypothesized that taurine lowers oxidative stress and the related harmful insulin resistance, thereby reducing morbidity and mortality.

Objective: Our primary objective is to reduce morbidity and consequent mortality in the elderly hip fracture patient by the administration of taurine.

Study design: A double blind placebo controlled intervention study at the surgery department of the Medical Center Alkmaar. The study consists of three parts: 1. A dose finding study; 2. Main study: outcome study on morbidity and mortality; 3. A study on insulin resistance, parallel to the main study.

Study population: Patients of both genders and any ethnicity, who will undergo primary surgery for a hip fracture, aged over 75 years, will be eligible for the study.

Intervention: Patients will receive from the moment of admission oral administration of taurine (3g/day or 6g/day, depending on results of the dose finding study) or placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 75 years old
  • hip fracture with a primary indication for surgery
  • having obtained his/her informed consent

排除标准

  • participating in another clinical trial

研究组 & 干预措施

1

Active Comparator

taurine will be given per capsule

干预措施: taurine (Dietary Supplement)

2

Placebo Comparator

placebo capsules containing microcrystalline cellulose will be given

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

morbidity and mortality

时间窗: 1 year

次要结局

  • postoperative delirium incidence, duration and severity(1 week)
  • antioxidant/oxidant parameters and inflammatory mediators(1 week)
  • postoperative insulin resistance(1 week)
  • mitochondrial dysfunction in the skeletal muscle(1 week)

研究者

发起方
Medical Center Alkmaar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander P.J. Houdijk

MD, PhD, surgeon

Medical Center Alkmaar

研究点 (2)

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