Hypohydration and Cardiorespiratory Function
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|ClinicalTrials.gov Identifier: NCT01949350|
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : October 12, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Dehydration||Dietary Supplement: Carbohydrate Dietary Supplement: Carbohydrate protein Dietary Supplement: Starved||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Clinical Observational Study of the Effect of Hypohydration Upon Cardiorespiratory Function|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|