Hypohydration and Cardiorespiratory Function
Primary Purpose
Dehydration
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Carbohydrate
Carbohydrate protein
Starved
Sponsored by
About this trial
This is an interventional basic science trial for Dehydration
Eligibility Criteria
Inclusion Criteria:
- Aged over 18 years
- Volunteers with capacity to give informed consent
- No underlying medical problems
- Comprehension Of English
Exclusion Criteria:
- 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
Sites / Locations
- Dept of perioperative and critical care medicine, Freeman Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Carbohydrate
Carbohydrate protein
Water
Arm Description
CHO loaded test:
CHO-P loaded test:
Starved as for surgery
Outcomes
Primary Outcome Measures
1) To determine whether a period of starvation prior to exercise testing adversely affects cardiorespiratory reserve as assessed by cardiopulmonary exercise (CPX) testing
Secondary Outcome Measures
Full Information
NCT ID
NCT01949350
First Posted
September 19, 2013
Last Updated
October 7, 2015
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01949350
Brief Title
Hypohydration and Cardiorespiratory Function
Official Title
Clinical Observational Study of the Effect of Hypohydration Upon Cardiorespiratory Function
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
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. Again, it has been shown that this type of drink is emptied from the stomach rapidly. They again will be asked to starve from midnight of the test
CARDIOPULMONARY EXERCISE TESTING
Cardiopulmonary exercise measurements are conducted in the consistent environment of the preassessment clinic in Clinic H, Freeman Hospital. CPX equipment includes an electronically braked cycle ergonometer, 12 lead ECG and a metabolic cart. The ECG allows online monitoring of all leads for rate and rhythm, and can measure changes in any S-T segment depression/elevation suggestive of cardiac ischaemia. The metabolic cart has oxygen and carbon dioxide analysers with a response time enabling breath-by-breath measurement. Calibration is ensured before each test. VO2, VCO2, heart rate, minute ventilation, and work rate are displayed continuously throughout the test.
Setting up the CPX test Patients have ECG leads applied before getting on the bike, and are coached on the mouthpiece and communication during the test. They are instructed to give their 'best effort' but to stop if they feel dizzy or faint. The increment in work rate is predetermined using equations for an estimate of expected work capacity, to aim for the test duration to be approximately 6-10 minutes.
CPX Test protocol Initially, 2 - 5 minutes of resting data is performed, ensuring patient comfort, and that the Respiratory Exchange Ratio (RER) falls below 1, indication the patient is not hyperventilating. Next, there is 1-3 minutes of unloaded cycling, followed by a graded increase in incremental workload. The leg speed throughout the test is maintained at 50-60 rpm to ensure constant effort. The patient is given verbal feedback and encouragement throughout the test. The test is stopped by the patient due to fatigue, pain, light headedness, or when they fail to maintain greater than 30 rpm for more than one minute despite encouragement. On completion of the exercise phase of the test, the patient is further monitored during the recovery period until heart rate reaches within 10% of pre-test, and all ST segments have normalised if applicable.
Exercise data processing Results are presented in standard nine-panel format compiled by CPX software. Further analysis for sub maximal parameters related to cardiopulmonary reserve is undertaken by trained personnel
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate
Arm Type
Active Comparator
Arm Description
CHO loaded test:
Arm Title
Carbohydrate protein
Arm Type
Active Comparator
Arm Description
CHO-P loaded test:
Arm Title
Water
Arm Type
Active Comparator
Arm Description
Starved as for surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate
Other Intervention Name(s)
Preload
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate protein
Other Intervention Name(s)
Highfive energy source 4:1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Starved
Other Intervention Name(s)
Water
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged over 18 years
Volunteers with capacity to give informed consent
No underlying medical problems
Comprehension Of English
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Prentis, MBBS
Organizational Affiliation
Newcastle-upon-Tyne Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of perioperative and critical care medicine, Freeman Hospital
City
Newcastle upon tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE77DN
Country
United Kingdom
12. IPD Sharing Statement
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Hypohydration and Cardiorespiratory Function
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