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Completed

NCT Number: NCT00500981

Internal Jugular Vein Ultrasound Measures and Fluid Responsiveness in Post-Operative Cardiac Surgical Patients

The goal of this study is to evaluate whether measures of the size of the internal jugular vein have clinical utility in predicting whether patients may benefit from treatment with intravenous fluid.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N-2T9, Canada

About this study

The optimal therapy for numerous disease states involves the replenishment of intravascular volume. Unfortunately, our current clinical measures of volume status are imperfect. Given biologic plausibility and preliminary study, it is possible that static and/or dynamic measures of internal jugular vein (IJV) size may correlate with volume status and/or be associated with volume responsiveness. If so, this type of assessment might be a more ideal clinical volume-assessment tool. This pilot study aims to establish proof of concept via evaluation of this question in patients following cardiac surgery.

This is a prospective observational study of physiologically-stable, ventilated patients post-cardiac surgery. The primary objective of this study is to evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients. A secondary objective is to evaluate the relationship between dynamic variations in the size of the right IJV related to respiration and leg-raising and fluid responsiveness in the same group. Static and dynamic ultrasound measurements of the right IJV will be performed pre-volume challenge.

Volume responsiveness will be independently assessed by cardiac index measurement before and after rapid infusion of 10% pentastarch. 30 subjects will be recruited pre-operatively and informed consent obtained. Stability of sedation, mechanical ventilation, and hemodynamics will be assured prior to initiation of measurements. Baseline static and respiratory dynamic ultrasound measurements of the right IJV will be obtained and then repeated after bilateral leg-raising. Baseline hemodynamics and cardiac outputs will be obtained using indwelling pulmonary artery catheters. A standardized volume challenge of 10% pentastarch given over 15 minutes will then be provided followed by repeat hemodynamic and cardiac output measurements.

Offline measurements of IJV size will be obtained from unmodified stored video loops by a single observer blinded to patient identity, hemodynamic, and fluid response data. Fluid responsiveness will be assessed by examining the change in cardiac index after volume challenge with a fluid responsive state defined as an increase of ≥ 12 % of cardiac index after volume challenge. The relationship between volume responsiveness and IJ ultrasound measures will be evaluated continuously and dichotomously.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (>18 years old)
  • Able to provide advanced informed consent
  • Planned elective or semi-urgent cardiac surgery

Exclusion criteria

  • Severe tricuspid regurgitation or planned tricuspid valve surgery
  • Congenital heart disease associated with cardiac shunting
  • Pre or post-operative presence of an intra-aortic balloon pump
  • Severe chronic obstructive pulmonary disease
  • Hemodynamic instability such that inotropes/vasopressor dosing is not constant
  • Respiratory instability and/or need for PEEP > 5 cmH20

Treatment and study plan

Volume challenge

Procedure

Ultrasound evaluation of internal jugular vein

Procedure

Primary outcomes

  1. To evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients.

    Time frame: 1 hour

Secondary outcomes

  1. To evaluate the relationship between dynamic variations in the size of the right IJV related to respiration and leg-raising and fluid responsiveness in ventilated post-operative cardiac surgical patients.

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Department of Critical Care Medicine

Registry information

Official study title

Do Internal Jugular Vein Measurements Made By Ultrasound Correlate With Fluid Responsiveness in Ventilated Post-Operative Cardiac Surgical Patients?

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jul 13, 2007
Registry last updated
Jul 26, 2012

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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