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Hypohydration and Cardiorespiratory Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01949350
First Posted: September 24, 2013
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
  Purpose

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 Intervention
Dehydration Dietary Supplement: Carbohydrate Dietary Supplement: Carbohydrate protein Dietary Supplement: Starved

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

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 [ Time Frame: 14 days ]

Enrollment: 26
Study Start Date: February 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
Dept of perioperative and critical care medicine, Freeman Hospital
Newcastle upon tyne, Tyne and Wear, United Kingdom, NE77DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: James Prentis, MBBS Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01949350     History of Changes
Other Study ID Numbers: 6790
First Submitted: September 19, 2013
First Posted: September 24, 2013
Last Update Posted: October 12, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes