Oral Fluid Volume Expansion

Dehydration Clinical Trial

— OFVEX  

Official title:

Oral Fluid: Absorption and Expansion of the Blood Volume

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360333
• Other study ID #: OFVEX
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: May 11, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy volunteer

• 18 to 50 years old

Exclusion Criteria:

• medication

• any chronical disease

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dehydration
• Hydration

Intervention

Other:
• tap water, sodium chloride, carbohydrate rich fluid
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.

Locations

Country	Name	City	State
Sweden	Intensive Care Unit, University Hospital	Linkoeping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hydration	volume kinetics: calculation from hemoglobin variations	2.5 hours	No
Secondary	fluid kinetic effects of oral carbohydrates	Electrolytes and blod glucose will be measured to se how much these are affected by the glucose upptake.	2.5 hours	No