NCT01062776

Kinetic Method to Detect Dehydration

New Method to Detect Dehydration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sodertalje Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Dehydration

Interventions

Type	Name	Description
BIOLOGICAL	Dehydration	Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.
BIOLOGICAL	Placebo	No dehydration is induced

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-02-04
• Last updated: 2010-08-19

Locations

1 site across 1 country: Sweden