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Kinetic Method to Detect Dehydration

Primary Purpose

Dehydration

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Dehydration
Placebo
Sponsored by
Sodertalje Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dehydration focused on measuring dehydration, fluid therapy, pharmacokinetics, hemoglobin

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Intensive Care, University hospital, Linköping, Sweden

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

5 ml/kg of fluid, no dehydration

10 ml/kg of fluid, no dehydration

5 ml/kg of fluid, dehydration

10 ml/kg of fluid, dehydration

Arm Description

Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.

Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.

Volunteers receive an intravenous infusion of 5 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.

Volunteers receive an intravenous infusion of 10 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.

Outcomes

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.

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

Full Information

First Posted
February 3, 2010
Last Updated
August 18, 2010
Sponsor
Sodertalje Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01062776
Brief Title
Kinetic Method to Detect Dehydration
Official Title
New Method to Detect Dehydration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sodertalje Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
dehydration, fluid therapy, pharmacokinetics, hemoglobin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 ml/kg of fluid, no dehydration
Arm Type
Placebo Comparator
Arm Description
Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.
Arm Title
10 ml/kg of fluid, no dehydration
Arm Type
Placebo Comparator
Arm Description
Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.
Arm Title
5 ml/kg of fluid, dehydration
Arm Type
Experimental
Arm Description
Volunteers receive an intravenous infusion of 5 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.
Arm Title
10 ml/kg of fluid, dehydration
Arm Type
Experimental
Arm Description
Volunteers receive an intravenous infusion of 10 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.
Intervention Type
Biological
Intervention Name(s)
Dehydration
Other Intervention Name(s)
Furosemide för intravenous administration, Acetated Ringer´s solution
Intervention Description
Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Acetated Ringer´s solution
Intervention Description
No dehydration is induced
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Hahn, MD, PhD
Organizational Affiliation
Södertälje Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Intensive Care, University hospital, Linköping, Sweden
City
Linköping
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33957864
Citation
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.
Results Reference
derived

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Kinetic Method to Detect Dehydration

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