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

This study has been completed.
Sponsor:
Collaborator:
Department of Critical Care Medicine
Information provided by (Responsible Party):
Dr. Dan Zuege, University of Calgary
ClinicalTrials.gov Identifier:
NCT00500981
First received: July 11, 2007
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Fluid Therapy
Cardiac Surgical Procedures
Procedure: Volume challenge
Procedure: Ultrasound evaluation of internal jugular vein
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Do Internal Jugular Vein Measurements Made By Ultrasound Correlate With Fluid Responsiveness in Ventilated Post-Operative Cardiac Surgical Patients?

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous fluid bolus
Administration of 500 ml of 10% pentastarch
Procedure: Volume challenge Procedure: Ultrasound evaluation of internal jugular vein

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500981

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N-2T9
Sponsors and Collaborators
University of Calgary
Department of Critical Care Medicine
Investigators
Principal Investigator: Dan Zuege, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Dan Zuege, Clinical Associate Professor of Medicine, University of Calgary
ClinicalTrials.gov Identifier: NCT00500981     History of Changes
Other Study ID Numbers: 20855
Study First Received: July 11, 2007
Last Updated: July 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Fluid responsiveness

ClinicalTrials.gov processed this record on November 20, 2014