Oral Fluid Volume Expansion (OFVEX)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dehydration Hydration |
Other: tap water, sodium chloride, carbohydrate rich fluid |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Oral Fluid: Absorption and Expansion of the Blood Volume |
- change in hydration [ Time Frame: 2.5 hours ] [ Designated as safety issue: No ]volume kinetics: calculation from hemoglobin variations
- fluid kinetic effects of oral carbohydrates [ Time Frame: 2.5 hours ] [ Designated as safety issue: No ]Electrolytes and blod glucose will be measured to se how much these are affected by the glucose upptake.
| Enrollment: | 10 |
| Study Start Date: | May 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Tap water, sodium chloride, carbohydrate rich fluid |
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy volunteer
- 18 to 50 years old
Exclusion Criteria:
- medication
- any chronical disease
Contacts and Locations| Sweden | |
| Intensive Care Unit, University Hospital | |
| Linkoeping, Sweden | |
| Principal Investigator: | Joachim Zdolsek, MD, PhD | University Hospital, Linköping, Sweden |
More Information
No publications provided
| Responsible Party: | Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping |
| ClinicalTrials.gov Identifier: | NCT01360333 History of Changes |
| Other Study ID Numbers: | OFVEX |
| Study First Received: | May 23, 2011 |
| Last Updated: | May 11, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital, Linkoeping:
|
Dehydration Hydration |
Additional relevant MeSH terms:
|
Dehydration Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013