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Completed

NCT Number: NCT03893513

Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000

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Key information

Conditions

Hemodynamic Monitoring

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18.5 - 35 kg/m^2

Exclusion criteria

  • Heart function abnormalities (arrhythmia, AV block, using pacemaker, severe aorta stenosis)
  • Morbid obesity
  • Bradycardia (< 50 bpm)
  • Tachycardia (> 110 bpm)
  • refuse to participate

Treatment and study plan

Transthoracic Electrical Bioimpedance

Device

Non-invasive hemodynamic monitor

Other names: ICON

Pulse Contour Analysis

Device

Invasive hemodynamic monitor

Other names: EV1000

Primary outcomes

  1. Hemodynamic correlation

    Time frame: Intraoperative

    Correlation between hemodynamic measured between devices: cardiac index, stroke volume index, systemic vascular resistance index, stroke volume index

Secondary outcomes

  1. Changes in hemodynamic profiles: Cardiac Index

    Time frame: Intraoperative

    The trends of perioperative hemodynamic profiles during and after surgery: cardiac index in L/minutes/m^2

  2. Changes in hemodynamic profiles: Stroke Volume Index

    Time frame: Intraoperative

    The trends of perioperative haemodynamic profiles during and after surgery: stroke volume index in mL/beat/m^2

  3. Changes in hemodynamic profiles: Systemic Vascular Resistance Index

    Time frame: Intraoperative

    The trends of perioperative haemodynamic profiles during and after surgery: systemic vascular resistance index in dynes-second-m^2/cm^5

  4. Changes in hemodynamic profiles: Stroke Volume Variation

    Time frame: Intraoperative

    The trends of perioperative haemodynamic profiles during and after surgery: stroke volume variation in %

Sponsors and collaborators

Lead sponsor

Dita Aditianingsih

Other

Registry information

Official study title

Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients: Analysis of Intraoperative Cardiac Output, Systemic Vascular Resistant and Stroke Volume Variation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2019
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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