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
  Purpose
  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.

Condition Intervention Phase
Dehydration
Biological: Dehydration
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: New Method to Detect Dehydration

Resource links provided by NLM:


Further study details as provided by Sodertalje Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Placebo
No dehydration is induced
Other Name: Acetated Ringer´s solution
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.
Biological: Placebo
No dehydration is induced
Other Name: Acetated Ringer´s solution
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.
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
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.
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

Detailed Description:
  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.
  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01062776

Locations
Sweden
Department of Intensive Care, University hospital, Linköping, Sweden
Linköping, Sweden, 58185
Sponsors and Collaborators
Sodertalje Hospital
Investigators
Study Director: Robert G Hahn, MD, PhD Södertälje Hospital
  More Information

No publications provided

Responsible Party: Robert Hahn, Södertälje Hospital
ClinicalTrials.gov Identifier: NCT01062776     History of Changes
Other Study ID Numbers: M114-09
Study First Received: February 3, 2010
Last Updated: August 18, 2010
Health Authority: Sweden: Institutional Review Board

Keywords provided by Sodertalje Hospital:
dehydration
fluid therapy
pharmacokinetics
hemoglobin

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Furosemide
Pharmaceutical Solutions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014