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Completed

NCT Number: NCT01062776

Kinetic 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.

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Key information

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Intensive Care, University hospital, Linköping, Sweden

Linköping, 58185, Sweden

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dehydration

Biological

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

Placebo

Biological

No dehydration is induced

Other names: Acetated Ringer´s solution

Primary outcomes

  1. 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 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

    Time frame: May 2010 (preliminary analysis)

Sponsors and collaborators

Lead sponsor

Sodertalje Hospital

Other

Registry information

Official study title

New Method to Detect Dehydration

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Aug 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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