Changes in body fluid parameters measured by bioimpedance spectroscopy in response to different types of fluid infused in healthy volunteers

A Clinical Trial to Evaluate the Changes in Intracelluar Water, Extracelluar Water, and their Ratio, measured by Bioempedance Spectroscopy, in Response to the Volume of hypotonic crystalloid, isotonic crystalloid and Colloid infused in Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001791

Enrollment

Registered

2016-02-01

Start date

2014-09-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Hypotonic, isotonic crystalloid or colloid solution (A: 40 ml/kg of Hartmann solution, B: 1000 ml of Volulyte®, C: 20 ml/kg of 5% Dextrose solution, D: 1000 ml of Pentaspan®) are intravenously

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -body mass index 18.5-25 kg per square meter -volunteers who consented to participate in the trial

Exclusion criteria

Exclusion criteria: -previously diagnosed hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychotic, hematooncologic, cardiovascular disease or clinically equivalent disease -hemoglobin < 10 g/dl -estimated glomerular filtration rate < 60 ml/min -participated in clinical trial of other drugs within 60 days before screening -donated blood more than 450 ml within 60 days before screening -hepatitis B or C carrier, previously diagnosed syphilis, acquired immunodeficiency disease -hyperhidrosis -experience of acute disease which can cause dehydration (ex,. diarrhea, acute gastroenteritis) within 3 days before fluid administration -Alcohol intake within 3 days before fluid administration -Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Change of intracellular, extracellular, and their ratio compared to baseline value in bioimpedance spectroscopy	—

Secondary

Measure	Time frame
Plasma and blood volume measured by indocyanin green dilution technique;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

rios76@hanmail.net

Outcome results