DehydrationPhase 1NCT01062776
Kinetic Method to Detect Dehydration
A Phase 1 study testing Dehydration in people with Dehydration, run by Sodertalje Hospital at 1 site in Sweden.
Trial summary
1. The distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration. 2. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Dehydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 1
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male.
Who cannot join
- Disease for which daily medication is required.
- Poor peripheral perfusion; defined as a perfusion index, as measured by Masimo´s Radical 7, of 2 or less.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Intensive Care, University hospital, Linköping, Sweden
Linköping, Linköping, 58185
About this study
Official title: New Method to Detect Dehydration
- The distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration.
- The hypothesis of the present study is that the elimination of infused fluid is retarded in the presence of dehydration, and that volume kinetics would therefore be capable of detecting dehydration in human subjects.
- We induce dehydration by injection graded doses of furosemide (a diuretic drug) in healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to when the same volunteer receives the same fluid without being in a dehydrated state.
Read the detailed description
- Fifteen healthy male volunteers are subjected to 4 experiments. They drink 800 ml of water at 6:00 AM to make sure they are not dehydrated when the experiments begin.
- On two occasions the volunteer receives, at 9:00 AM, an intravenous infusion of acetated Ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. The blood hemoglobin concentration is measured during 16 occasions during 120 min by invasive blood sampling and also non-invasively by a pulse oximeter (Masimo´s Radical 7).
- On two other occasions, the infusions are preceded for 2 hours of deliberate dehydration. Doses of furosemide 5 mg are repeated 3-4 times with the goal of creating dehydration amounting to approximately 2 liters of fluid. Excreted urine is collected and the volume measured.
- The kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration.
- The accuracy and precision of the non-invasive monitoring of Hgb can be determined.
- The study is ended with that the Hgb response between the lying and sitting position is compared and with that the fluid balance is restored by ingestion of water.
- Experiments are performed in the Department of Intensive Care at Linköping University Hospital, Sweden.
- Conditions
- Dehydration
- Being tested
- Dehydration, Placebo
- Keywords
- dehydration, fluid therapy, pharmacokinetics, hemoglobin
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydrationBiological
Also called Furosemide för intravenous administration, Acetated Ringer´s solution
Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.
PlaceboBiological
Also called Acetated Ringer´s solution
No dehydration is induced
| Study group | Role | What they receive |
|---|---|---|
| 5 ml/kg of fluid, no dehydration | Placebo comparator | Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide. Receives: Biological: Placebo |
| 10 ml/kg of fluid, no dehydration | Placebo comparator | Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide. Receives: Biological: Placebo |
| 5 ml/kg of fluid, dehydration | Experimental | Volunteers receive an intravenous infusion of 5 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide. Receives: Biological: Dehydration |
| 10 ml/kg of fluid, dehydration | Experimental | Volunteers receive an intravenous infusion of 10 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide. Receives: Biological: Dehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
As determined by volume kinetics, a healthy human male eliminates infused crystalloid fluid more slowly when being in the dehydrated state as compared to when being normohydrated.
Measured: December 2010
Secondary outcomes (1)
The volume kinetics of an infusion fluid can/can not be measured as accurately by non-invasive monitoring as by invasive monitoring of the blood hemoglobin concentration
Measured: May 2010 (preliminary analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodertalje Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Robert G Hahn, MD, PhD, Study director, Södertälje Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062776
- Sponsor's protocol ID
- M114-09
- Status last verified
- Nov 2009
- First submitted
- 3 Feb 2010
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahn RG, Zdolsek M, Gunnstrom M, Hasselgren E, Zdolsek JH. Diuretic responses to Ringer's solution and 20% albumin at different arterial pressures. Physiol Rep. 2024 Oct;12(19):e70069. doi: 10.14814/phy2.70069.
PubMed 39375158Hahn 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 33957864
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Method to Detect Dehydration
- ClinicalTrials.gov ID
- NCT01062776
- Acronym / sponsor ID
- M114-09
- Conditions
- Dehydration
- Keywords
- dehydration, fluid therapy, pharmacokinetics, hemoglobin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sodertalje HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Feb 2010 (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.
- The distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration.
- The hypothesis of the present study is that the elimination of infused fluid is retarded in the presence of dehydration, and that volume kinetics would therefore be capable of detecting dehydration in human subjects.
- We induce dehydration by injection graded doses of furosemide (a diuretic drug) in healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to when the same volunteer receives the same fluid without being in a dehydrated state.
Detailed description
- Fifteen healthy male volunteers are subjected to 4 experiments. They drink 800 ml of water at 6:00 AM to make sure they are not dehydrated when the experiments begin.
- On two occasions the volunteer receives, at 9:00 AM, an intravenous infusion of acetated Ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. The blood hemoglobin concentration is measured during 16 occasions during 120 min by invasive blood sampling and also non-invasively by a pulse oximeter (Masimo´s Radical 7).
- On two other occasions, the infusions are preceded for 2 hours of deliberate dehydration. Doses of furosemide 5 mg are repeated 3-4 times with the goal of creating dehydration amounting to approximately 2 liters of fluid. Excreted urine is collected and the volume measured.
- The kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration.
- The accuracy and precision of the non-invasive monitoring of Hgb can be determined.
- The study is ended with that the Hgb response between the lying and sitting position is compared and with that the fluid balance is restored by ingestion of water.
- Experiments are performed in the Department of Intensive Care at Linköping University Hospital, Sweden.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 ml/kg of fluid, no dehydration | Placebo comparator | Biological: PlaceboVolunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide. |
| 10 ml/kg of fluid, no dehydration | Placebo comparator | Biological: PlaceboVolunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide. |
| 5 ml/kg of fluid, dehydration | Experimental | Biological: DehydrationVolunteers receive an intravenous infusion of 5 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide. |
| 10 ml/kg of fluid, dehydration | Experimental | Biological: DehydrationVolunteers receive an intravenous infusion of 10 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male.
Key exclusion criteria (2 listed)
- Disease for which daily medication is required.
- Poor peripheral perfusion; defined as a perfusion index, as measured by Masimo´s Radical 7, of 2 or less.
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 |
|---|---|---|
| DehydrationAlso: Furosemide för intravenous administration, Acetated Ringer´s solutionFurosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost. | Biological | 10 ml/kg of fluid, dehydration, 5 ml/kg of fluid, dehydration |
| PlaceboAlso: Acetated Ringer´s solutionNo dehydration is induced | Biological | 10 ml/kg of fluid, no dehydration, 5 ml/kg of fluid, no dehydration |
Primary outcome
As determined by volume kinetics, a healthy human male eliminates infused crystalloid fluid more slowly when being in the dehydrated state as compared to when being normohydrated.
Time frame: December 2010
1 secondary outcome
The volume kinetics of an infusion fluid can/can not be measured as accurately by non-invasive monitoring as by invasive monitoring of the blood hemoglobin concentration
Time frame: May 2010 (preliminary analysis)
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 19 Aug 2010.
- Derived from this study: PubMed 39375158Hahn RG, Zdolsek M, Gunnstrom M, Hasselgren E, Zdolsek JH. Diuretic responses to Ringer's solution and 20% albumin at different arterial pressures. Physiol Rep. 2024 Oct;12(19):e70069. doi: 10.14814/phy2.70069.
- 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.
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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.
Robert G Hahn, MD, PhD study director
Södertälje Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dehydration in people with Dehydration, run by Sodertalje Hospital 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 1 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 19 Aug 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
As determined by volume kinetics, a healthy human male eliminates infused crystalloid fluid more slowly when being in the dehydrated state as compared to when being normohydrated. (time frame: December 2010). 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 NCT01062776, 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 19 Aug 2010; AzTrials last refreshed its copy on 31 Oct 2026.