Kinetic Method to Detect Dehydration

NCT01062776 | Completed Phase 1

• 1 other identifier: M114-09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Dehydration

Keywords

dehydration; fluid therapy; pharmacokinetics; hemoglobin

Outcome Measures

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.

  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

  May 2010 (preliminary analysis)

Study Arms (4)

5 ml/kg of fluid, no dehydration

PLACEBO COMPARATOR

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

Biological: Placebo

10 ml/kg of fluid, no dehydration

PLACEBO COMPARATOR

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

Biological: Placebo

5 ml/kg of fluid, dehydration

EXPERIMENTAL

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

Biological: Dehydration

10 ml/kg of fluid, dehydration

EXPERIMENTAL

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

Biological: Dehydration

Interventions

Dehydration BIOLOGICAL

Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.

Also known as: Furosemide för intravenous administration, Acetated Ringer´s solution

10 ml/kg of fluid, dehydration; 5 ml/kg of fluid, dehydration

Placebo BIOLOGICAL

No dehydration is induced

Also known as: Acetated Ringer´s solution

10 ml/kg of fluid, no dehydration; 5 ml/kg of fluid, no dehydration

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sodertalje Hospital: lead

Study Sites (1)

Department of Intensive Care, University hospital, Linköping, Sweden

Linköping, Linköping, 58185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33957864 DERIVED

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert G Hahn, MD, PhD

  Södertälje Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 19, 2010

Record last verified: 2009-11

Locations

SE (1)