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.

Study Overview

• Status: Completed
• Conditions: Dehydration
• Intervention / Treatment: Biological: Placebo; Biological: Dehydration

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • Department of Intensive Care, University hospital, Linköping, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	December 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
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	May 2010 (preliminary analysis)

Collaborators and Investigators

• Sponsor: Sodertalje Hospital
• Investigators: Study Director: Robert G Hahn, MD, PhD, Södertälje Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 19, 2010
• Last Update Submitted That Met QC Criteria: August 18, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: hemoglobin; pharmacokinetics; dehydration; fluid therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Pharmaceutical Solutions; Furosemide
• Other Study ID Numbers: M114-09