Oral Fluid Volume Expansion (OFVEX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01360333
First received: May 23, 2011
Last updated: May 11, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • change in hydration [ Time Frame: 2.5 hours ] [ Designated as safety issue: No ]
    volume kinetics: calculation from hemoglobin variations


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • healthy volunteer
  • 18 to 50 years old

Exclusion Criteria:

  • medication
  • any chronical disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360333

Locations
Sweden
Intensive Care Unit, University Hospital
Linkoeping, Sweden
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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 September 22, 2014