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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01360333
Other study ID # OFVEX
Secondary ID
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


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
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