Hypohydration and Cardiorespiratory Function
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.
|Dehydration||Dietary Supplement: Carbohydrate Dietary Supplement: Carbohydrate protein Dietary Supplement: Starved|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
|Official Title:||Clinical Observational Study of the Effect of Hypohydration Upon Cardiorespiratory Function|
- 1) To determine whether a period of starvation prior to exercise testing adversely affects cardiorespiratory reserve as assessed by cardiopulmonary exercise (CPX) testing [ Time Frame: 14 days ]
|Study Start Date:||February 2014|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Carbohydrate
CHO loaded test:
Dietary Supplement: Carbohydrate
Participants will be asked to drink an isotonic carbohydrate loaded drink (preload)night before the test and also two hours prior to the CPX test.
Other Name: Preload
Active Comparator: Carbohydrate protein
CHO-P loaded test:
Dietary Supplement: Carbohydrate protein
Participants will be asked to drink an isotonic carbohydrate drink (Highfive energy source 4:1)the night prior to the test and also two hours prior to the CPX test.
Other Name: Highfive energy source 4:1
Active Comparator: Water
Starved as for surgery
Dietary Supplement: Starved
Participants will be asked to starve as per normal clinical requirements for surgery. They are allowed to drink water upto 2 hours prior to the CPX test
Other Name: Water
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01949350
|Dept of perioperative and critical care medicine, Freeman Hospital|
|Newcastle upon tyne, Tyne and Wear, United Kingdom, NE77DN|
|Principal Investigator:||James Prentis, MBBS||Newcastle-upon-Tyne Hospitals NHS Trust|