DehydrationOFVEXNCT01360333
Oral Fluid Volume Expansion
A study testing tap water, sodium chloride, carbohydrate rich fluid in people with Dehydration and Hydration, run by University Hospital, Linkoeping at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Hydration
- What is being tested?
- tap water, sodium chloride, carbohydrate rich fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer
- 18 to 50 years old
Who cannot join
- medication
- any chronical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Fluid: Absorption and Expansion of the Blood Volume
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.
Read more
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.
Read the 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.
- Conditions
- Dehydration, Hydration
- Being tested
- tap water, sodium chloride, carbohydrate rich fluid
- Keywords
- Dehydration, Hydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tap water, sodium chloride, carbohydrate rich fluidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tap water, sodium chloride, carbohydrate rich fluid | Other | Not described Receives: Other: tap water, sodium chloride, carbohydrate rich fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hydration
volume kinetics: calculation from hemoglobin variations
Measured: 2.5 hours
Secondary outcomes (1)
fluid kinetic effects of oral carbohydrates
Electrolytes and blod glucose will be measured to se how much these are affected by the glucose upptake.
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Zdolsek, University Hospital, Linkoeping
- Investigators
- Joachim Zdolsek, MD, PhD, Principal investigator, University Hospital, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360333
- Sponsor's protocol ID
- OFVEX
- Acronym
- OFVEX
- Status last verified
- May 2012
- First submitted
- 23 May 2011
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33957864Zdolsek 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.
PubMed 27471593
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Fluid: Absorption and Expansion of the Blood Volume
- ClinicalTrials.gov ID
- NCT01360333
- Acronym / sponsor ID
- OFVEX / OFVEX
- Conditions
- Dehydration, Hydration
- Keywords
- Dehydration, Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tap water, sodium chloride, carbohydrate rich fluid | Other | Other: tap water, sodium chloride, carbohydrate rich fluid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteer
- 18 to 50 years old
Key exclusion criteria (2 listed)
- medication
- any chronical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tap water, sodium chloride, carbohydrate rich fluidIngestion of three different fluids at three different occasions separated by at least one week, A, Tap water. B. Sodium Chloride. C. Carbohydrate rich fluid. | Other | Tap water, sodium chloride, carbohydrate rich fluid |
Primary outcome
change in hydration
Time frame: 2.5 hours
volume kinetics: calculation from hemoglobin variations
1 secondary outcome
fluid kinetic effects of oral carbohydrates
Time frame: 2.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
- Derived from this study: PubMed 33957864Hahn 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.
- Derived from this study: PubMed 27471593Zdolsek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Zdolsek, MD, PhD principal investigator
University Hospital, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tap water, sodium chloride, carbohydrate rich fluid in people with Dehydration and Hydration, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in hydration (time frame: 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01360333, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012; AzTrials last refreshed its copy on 27 Oct 2026.