NCT01949350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

September 19, 2013

Last Update Submit

October 7, 2015

Conditions

Dehydration

Outcome Measures

Primary Outcomes (1)

  • 1) To determine whether a period of starvation prior to exercise testing adversely affects cardiorespiratory reserve as assessed by cardiopulmonary exercise (CPX) testing

    14 days

Study Arms (3)

Carbohydrate

ACTIVE COMPARATOR

CHO loaded test:

Dietary Supplement: Carbohydrate

Carbohydrate protein

ACTIVE COMPARATOR

CHO-P loaded test:

Dietary Supplement: Carbohydrate protein

Water

ACTIVE COMPARATOR

Starved as for surgery

Dietary Supplement: Starved

Interventions

CarbohydrateDIETARY_SUPPLEMENT

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.

Also known as: Preload
Carbohydrate
Carbohydrate proteinDIETARY_SUPPLEMENT

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.

Also known as: Highfive energy source 4:1
Carbohydrate protein
StarvedDIETARY_SUPPLEMENT

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

Also known as: Water
Water

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged over 18 years
  • Volunteers with capacity to give informed consent
  • No underlying medical problems
  • Comprehension Of English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of perioperative and critical care medicine, Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE77DN, United Kingdom

Location

MeSH Terms

Conditions

Dehydration

Interventions

CarbohydratesWater

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • James Prentis, MBBS

    Newcastle-upon-Tyne Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

GB(1)