Clinical Observational Study of the Effect of Hypohydration Upon Cardiorespiratory Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- 1) To determine whether a period of starvation prior to exercise testing adversely affects cardiorespiratory reserve as assessed by cardiopulmonary exercise (CPX) testing
研究概览
简要总结
Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, measurement of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, has been shown to be predictive of outcome following non-cardiac surgery. All patients prior to major surgery are starved for a minimum of 6 hours and often longer prior to major elective surgery. It has been shown that elite athletes who are hypohydrated have reduced exercise capacity and lower cardiorespiratory function. These results are further exaggerated in "non-trained" individuals. Therefore, the starvation policy prior to surgery may have a deleterious effect on outcome after surgery.
4.2 AIMS This is a pilot study of health volunteers to assess the role of carbohydrate (CHO) (preload) and carbohydrate-protein (CHO-P) (Highfive energy source 1 in 4) in improving aerobic capacity after a period of fasting mimicking the current starvation policy prior to surgery. Both of these have similar calorific value and only differ in the amount of carbohydrate and protein supplementation.
详细描述
2 OUTLINE OF STUDY METHODOLOGY (See Appendix D) The methodology of the testing is outlined below:-
STARVATION POLICY The three exercise tests will be undertaken on three separate days but at the same time in the morning to minimise the starvation time and ensure consistency. All patients will be asked not to partake in strenuous exercise 24 hours prior to the test as this could affect hydration and performance status.
Starvation exercise test Participants will be asked to starve from midnight prior to the test. They may have a small glass of water at 6am on the day of the test. This is in line with the current starvation policy at the Freeman Hospital.
CHO loaded test Participants will be asked to drink an isotonic carbohydrate loaded drink (preload) appendix E the night before the test and also two hours prior to the CPX test. This type of clear drink has been shown to be emptied from the stomach within 2 hours and as such can be administered safely on the day of surgery. They again will be asked to starve from midnight prior to the test.
CHO-P loaded test
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 18 years
- •Volunteers with capacity to give informed consent
- •No underlying medical problems
- •Comprehension Of English
排除标准
- •Volunteers who lack the ability to consent
- •Those unable to exercise
- •Those with contraindications to exercise testing (appendix A)
- •Diabetics - both insulin and non-insulin dependent diabetics due to the starvation period and carbohydrate load
- •Allergy to milk
研究组 & 干预措施
Carbohydrate
CHO loaded test:
干预措施: Carbohydrate (Dietary Supplement)
Carbohydrate protein
CHO-P loaded test:
干预措施: Carbohydrate protein (Dietary Supplement)
Water
Starved as for surgery
干预措施: Starved (Dietary Supplement)
结局指标
主要结局
1) To determine whether a period of starvation prior to exercise testing adversely affects cardiorespiratory reserve as assessed by cardiopulmonary exercise (CPX) testing
时间窗: 14 days
次要结局
未报告次要终点