DehydrationNCT01949350
Hypohydration and Cardiorespiratory Function
A study testing Carbohydrate, Carbohydrate protein and Starved in people with Dehydration, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Carbohydrate, Carbohydrate protein and Starved
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Volunteers with capacity to give informed consent
- No underlying medical problems
- Comprehension Of English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dept of perioperative and critical care medicine, Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE77DN
About this study
Official title: Clinical Observational Study of the Effect of Hypohydration Upon 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.
Read the 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
- Conditions
- Dehydration
- Being tested
- Carbohydrate, Carbohydrate protein, Starved
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateDietary supplement
Also called Preload
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.
Carbohydrate proteinDietary supplement
Also called Highfive energy source 4:1
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.
StarvedDietary supplement
Also called Water
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
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate | Active comparator | CHO loaded test: Receives: Dietary Supplement: Carbohydrate |
| Carbohydrate protein | Active comparator | CHO-P loaded test: Receives: Dietary Supplement: Carbohydrate protein |
| Water | Active comparator | Starved as for surgery Receives: Dietary Supplement: Starved |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) To determine whether a period of starvation prior to exercise testing adversely affects cardiorespiratory reserve as assessed by cardiopulmonary exercise (CPX) testing
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Prentis, MBBS, Principal investigator, Newcastle-upon-Tyne Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949350
- Sponsor's protocol ID
- 6790
- Status last verified
- Oct 2015
- First submitted
- 19 Sep 2013
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observational Study of the Effect of Hypohydration Upon Cardiorespiratory Function
- ClinicalTrials.gov ID
- NCT01949350
- Acronym / sponsor ID
- 6790
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate | Active comparator | Dietary Supplement: CarbohydrateCHO loaded test: |
| Carbohydrate protein | Active comparator | Dietary Supplement: Carbohydrate proteinCHO-P loaded test: |
| Water | Active comparator | Dietary Supplement: StarvedStarved as for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged over 18 years
- Volunteers with capacity to give informed consent
- No underlying medical problems
- Comprehension Of English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbohydrateAlso: PreloadParticipants will be asked to drink an isotonic carbohydrate loaded drink (preload)night before the test and also two hours prior to the CPX test. | Dietary supplement | Carbohydrate |
| Carbohydrate proteinAlso: Highfive energy source 4:1Participants 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. | Dietary supplement | Carbohydrate protein |
| StarvedAlso: WaterParticipants 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 | Dietary supplement | Water |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Prentis, MBBS principal investigator
Newcastle-upon-Tyne Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate, Carbohydrate protein and Starved in people with Dehydration, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.