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Hypohydration and Cardiorespiratory Function

This study has been completed.
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust Identifier:
First received: September 19, 2013
Last updated: October 7, 2015
Last verified: October 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 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01949350

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
Principal Investigator: James Prentis, MBBS Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust Identifier: NCT01949350     History of Changes
Other Study ID Numbers: 6790
Study First Received: September 19, 2013
Last Updated: October 7, 2015

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes processed this record on August 18, 2017