Hypohydration and Cardiorespiratory Function

This study is not yet open for participant recruitment.
Verified September 2013 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01949350
First received: September 19, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  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 (1). 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 - appendix E) and carbohydrate-protein (CHO-P) (Highfive energy source 1 in 4 - appendix F) 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: Hypohydration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypohydration

CHO loaded test: 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.

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.

Dietary Supplement: Hypohydration

CHO loaded test: Participants will be asked to drink an isotonic carbohydrate loaded drink (preload) the night before the test and also two hours prior to the CPX 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.

Other Name: Highfive energy source 4:1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949350

Contacts
Contact: James Prentis, MBBS 0044 1912336161 james.prentis@nuth.nhs.uk

Locations
United Kingdom
Dept of perioperative and critical care medicine, Freeman Hospital Not yet recruiting
Newcastle upon tyne, Tyne and Wear, United Kingdom, NE77DN
Contact: James Prentis, MBBS    00441912336161    james.prentis@nuth.nhs.uk   
Principal Investigator: James Prentis, MBBS         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: James Prentis, MBBS Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01949350     History of Changes
Other Study ID Numbers: 6790
Study First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on April 22, 2014