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Bioimpedance Spectroscopy in Humans During Acute Fluid Volume Expansion With Different Crystalloid Solutions

Not Applicable
Completed
Conditions
HEALTHY
Interventions
Other: Treatment with 0.9% normal saline
Other: Treatment with D5+ 0.45 saline
Other: Treatment with D5
Registration Number
NCT01930578
Lead Sponsor
The Hospital for Sick Children
Brief Summary

The objective of the study is to identify a pattern of bioimpedance in humans during acute food changes. As a part of this study the investigators will be administering sodium bromide in oder to measure extracellular water via the bromide dilution technique.

Detailed Description

The resistance of the human body to the flow of alternating current is thought to be related to the volume of fluid within the body. The acute change in fluid status of the human body alters the body resistance. This change can be measured accurately with bioelectrical impedance and previous experiments confirmed this observation. However, previous experiments using a piglet model and subsequently humans, suggested that the changes observed is a result of changes in salt instead of body water.

An experiment has shown that bioimpedance analysis (BIA) was able to detect changes in total body resistance when different electrolyte solutions were infused. The changes in resistance were related to changes in osmolarity and electro-ionic state, not to volume of water infused. Therefore, BIA measures principally the electro-ionic state. Thus a measurement of fluid volume can be indirectly obtained from BIA. However, in the non-steady state such as acute fluid volume expansion, the measurement of water volume cannot be performed accurately.

In this study, we will be administering sodium bromide in oder to measure extracellular water via the bromide solution technique. Despite the interesting observations, the human study described above was underpowered. Therefore, we aim to validate the observations that have been previously made through carrying out an appropriately powered study with an adequate sample size to validate the observations noted.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Age > 18 years
  • Otherwise healthy with no medical history of: cardiac disease, renal disease, chronic liver disease, diabetes, or lymphedema
Exclusion Criteria
  • Allergy to bromide
  • Breast feeding mothers
  • Pregnancy
  • Heart failure
  • Presence of a pace maker
  • Renal failure
  • Any contraindication to fluid bolus
  • Recent or continued exposure to bromide containing drugs

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Treatment with 0.9% normal salineTreatment with 0.9% normal saline1 litre of normal saline infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with 0.9% normal salineTreatment with D51 litre of normal saline infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with D5Treatment with 0.9% normal saline1 litre of D5 infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with D5Treatment with D5+ 0.45 saline1 litre of D5 infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with D5, 0.45 salineTreatment with D5+ 0.45 saline1 litre of D5, 0.45 saline infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with 0.9% normal salineTreatment with D5+ 0.45 saline1 litre of normal saline infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with D5, 0.45 salineTreatment with D51 litre of D5, 0.45 saline infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with D5, 0.45 salineTreatment with 0.9% normal saline1 litre of D5, 0.45 saline infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Treatment with D5Treatment with D51 litre of D5 infused over minutes and BIS performed at baseline, and 5 minute intervals during infusion, then 5 minute interval readings for 15 minutes after the stop of the infusion.
Primary Outcome Measures
NameTimeMethod
Pattern of bioimpedance in humans during acute food changes.3 hours
Bioimpedance spectroscopy in humans3 hours

change in bioimpedance spectroscopy (MHz)in humans during acute fluid expansion as a result of administration of different intravenous crystalloid solutions

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Hospital for Sick Children

🇨🇦

Toronto, Ontario, Canada

The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
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