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

NCT01930578 | Completed

• 1 other identifier: 1000011897
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HEALTHY

Keywords

bioimpedance analysis; spectroscopy; electrolyte sodium bromide; extracellular water

Outcome Measures

Primary Outcomes (2)

• Pattern of bioimpedance in humans during acute food changes.

  3 hours

• Bioimpedance spectroscopy in humans

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

  3 hours

Study Arms (3)

Treatment with 0.9% normal saline

EXPERIMENTAL

1 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.

Other: Treatment with 0.9% normal saline; Other: Treatment with D5+ 0.45 saline; Other: Treatment with D5

Treatment with D5, 0.45 saline

EXPERIMENTAL

1 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.

Other: Treatment with 0.9% normal saline; Other: Treatment with D5+ 0.45 saline; Other: Treatment with D5

Treatment with D5

EXPERIMENTAL

1 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.

Other: Treatment with 0.9% normal saline; Other: Treatment with D5+ 0.45 saline; Other: Treatment with D5

Interventions

Treatment with 0.9% normal saline OTHER

An oral dose of 0.33ml/kg of 10% Sodium Bromide solution at each of 3 study visits. Each dose of Sodium Bromide will be mixed with an equivalent volume; 1:1 of sterile water before oral intake. An IV infusion of (1) 0.9% saline, (2) 5% Dextrose or (3) 3.3% Dextrose and 0.3% saline will be given at a rate of 1 liter over an hour in a randomized crossover design.

Treatment with 0.9% normal saline; Treatment with D5; Treatment with D5, 0.45 saline

Treatment with D5+ 0.45 saline OTHER

An oral dose of 0.33ml/kg of 10% Sodium Bromide solution at each of 3 study visits. Each dose of Sodium Bromide will be mixed with an equivalent volume; 1:1 of sterile water before oral intake. An IV infusion of (1) 0.9% saline, (2) 5% Dextrose or (3) 3.3% Dextrose and 0.3% saline will be given at a rate of 1 liter over an hour in a randomized crossover design.

Treatment with 0.9% normal saline; Treatment with D5; Treatment with D5, 0.45 saline

Treatment with D5 OTHER

An oral dose of 0.33ml/kg of 10% Sodium Bromide solution at each of 3 study visits. Each dose of Sodium Bromide will be mixed with an equivalent volume; 1:1 of sterile water before oral intake. An IV infusion of (1) 0.9% saline, (2) 5% Dextrose or (3) 3.3% Dextrose and 0.3% saline will be given at a rate of 1 liter over an hour in a randomized crossover design.

Treatment with 0.9% normal saline; Treatment with D5; Treatment with D5, 0.45 saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Otherwise healthy with no medical history of: cardiac disease, renal disease, chronic liver disease, diabetes, or lymphedema

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• Yap J, Rafii M, Azcue M, Pencharz P. Effect of Intravenous Infusion Solutions on Bioelectrical Impedance Spectroscopy. JPEN J Parenter Enteral Nutr. 2017 May;41(4):641-646. doi: 10.1177/0148607115619598. Epub 2015 Dec 4.

  PMID: 26637229 BACKGROUND

MeSH Terms

Interventions

Therapeutics; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Paul Pencharz, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Scientist

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 29, 2013
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CA (1)