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Oral Fluid Volume Expansion (OFVEX)

Primary Purpose

Dehydration, Hydration

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
tap water, sodium chloride, carbohydrate rich fluid
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dehydration focused on measuring Dehydration, Hydration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteer
  • 18 to 50 years old

Exclusion Criteria:

  • medication
  • any chronical disease

Sites / Locations

  • Intensive Care Unit, University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tap water, sodium chloride, carbohydrate rich fluid

Arm Description

Outcomes

Primary Outcome Measures

change in hydration
volume kinetics: calculation from hemoglobin variations

Secondary Outcome Measures

fluid kinetic effects of oral carbohydrates
Electrolytes and blod glucose will be measured to se how much these are affected by the glucose upptake.

Full Information

First Posted
May 23, 2011
Last Updated
May 11, 2012
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT01360333
Brief Title
Oral Fluid Volume Expansion
Acronym
OFVEX
Official Title
Oral Fluid: Absorption and Expansion of the Blood Volume
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
When subjected to fluid loss or fluid deficiency irrespective of disease or environmental factors it is discussed how to rehydrate or how to hydrate prophylactic. In medical care it is common to give infusions. However it has increasingly become common to hydrate the patient through the mouth even early after bowel surgery. Moreover it is more simple to provide energy the natural way. Which fluid to give, depends on several factors such as possibility to drink, the volume and emptying of the stomach as well as the fluid absorption in the bowel. The provided fluid can also influence this process depending on temperature, osmolality/tonicity and composition (carbohydrates or salts). In this study we wish to study the speed with which the provided fluid is absorbed by the bowels and how fast the fluid is distributed to the different body compartments depending on it's composition. The three fluids will be either tap water, high sodium chloride and a carbohydrate rich fluid.
Detailed Description
The healthy volunteer starts the study by voiding. Then he/she lies down for 30 minutes. A blood sample is drawn and thereafter the healthy volunteer ingests one of the three fluids. Blood samples are drawn 10 times during the following two hours. Finally the healthy volunteer is asked to void and the voided urine is measured. The hemoglobin concentrations are used to calculate the blood volume expansion with volume kinetic methods. The process is repeated another two times with the two remaining fluids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Hydration
Keywords
Dehydration, Hydration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tap water, sodium chloride, carbohydrate rich fluid
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
tap water, sodium chloride, carbohydrate rich fluid
Intervention Description
Ingestion of three different fluids at three different occasions separated by at least one week, A, Tap water. B. Sodium Chloride. C. Carbohydrate rich fluid.
Primary Outcome Measure Information:
Title
change in hydration
Description
volume kinetics: calculation from hemoglobin variations
Time Frame
2.5 hours
Secondary Outcome Measure Information:
Title
fluid kinetic effects of oral carbohydrates
Description
Electrolytes and blod glucose will be measured to se how much these are affected by the glucose upptake.
Time Frame
2.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteer 18 to 50 years old Exclusion Criteria: medication any chronical disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Zdolsek, MD, PhD
Organizational Affiliation
University Hospital, Linköping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, University Hospital
City
Linkoeping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33957864
Citation
Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.
Results Reference
derived
PubMed Identifier
27471593
Citation
Zdolsek J, Metander A, Hahn R. Volume kinetic evaluation of fluid turnover after oral intake of tap water, lemonade and saline in volunteers. BMC Sports Sci Med Rehabil. 2016 Jul 28;8:22. doi: 10.1186/s13102-016-0045-x. eCollection 2016.
Results Reference
derived

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Oral Fluid Volume Expansion

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