Kinetic Method to Detect Dehydration

This study has been completed.
Sponsor:
Information provided by:
Sodertalje Hospital
ClinicalTrials.gov Identifier:
NCT01062776
First received: February 3, 2010
Last updated: August 18, 2010
Last verified: November 2009

February 3, 2010
August 18, 2010
October 2009
May 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062776 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Kinetic Method to Detect Dehydration
New Method to Detect Dehydration
  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. 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.
  3. 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.
  1. 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.
  2. 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).
  3. 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.
  4. The kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration.
  5. The accuracy and precision of the non-invasive monitoring of Hgb can be determined.
  6. 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.
  7. Experiments are performed in the Department of Intensive Care at Linköping University Hospital, Sweden.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Dehydration
  • Biological: Dehydration
    Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.
    Other Names:
    • Furosemide för intravenous administration
    • Acetated Ringer´s solution
  • Biological: Placebo
    No dehydration is induced
    Other Name: Acetated Ringer´s solution
  • Placebo Comparator: 5 ml/kg of fluid, no dehydration
    Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.
    Intervention: Biological: Placebo
  • Placebo Comparator: 10 ml/kg of fluid, no dehydration
    Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.
    Intervention: Biological: Placebo
  • Experimental: 5 ml/kg of fluid, dehydration
    Volunteers receive an intravenous infusion of 5 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.
    Intervention: Biological: Dehydration
  • Experimental: 10 ml/kg of fluid, dehydration
    Volunteers receive an intravenous infusion of 10 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.
    Intervention: Biological: Dehydration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Male
20 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01062776
M114-09
No
Robert Hahn, Södertälje Hospital
Sodertalje Hospital
Not Provided
Study Director: Robert G Hahn, MD, PhD Södertälje Hospital
Sodertalje Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP