Kinetic Method to Detect Dehydration | NCT01062776 | Trialant
CompletedInterventionalPhase 1Updated Aug 19, 2010
Kinetic Method to Detect Dehydration
New Method to Detect Dehydration
ClinicalTrials.gov ID
NCT01062776
Lead Sponsor
Sodertalje HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
10Actual
Last Update Posted
Aug 19, 2010Estimated
Start Date
Oct 2009
Primary Completion Date
May 2010Actual
Completion Date
May 2010Actual
Official Title
New Method to Detect Dehydration
Brief Summary
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.
Dehydration
Dehydration
Placebo
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Healthy male.
Exclusion Criteria:
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.
Primary Purpose
Diagnostic
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Department of Intensive Care, University hospital, Linköping, Sweden