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

HEALTHY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930578
• Other study ID #: 1000011897
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: January 5, 2018
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HEALTHY

Intervention

Other:
• Treatment with 0.9% normal saline
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 D5+ 0.45 saline
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 D5
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of bioimpedance in humans during acute food changes.		3 hours
Primary	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