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Completed

NCT Number: NCT01656954

Predicting Volume Response Study

The purpose of this study is to understand and document measurements in heart stroke volume (the volume or amount of blood pumped per heart beat) and cardiac output (the volume or amount of blood pumped by your heart per minute) during a passive leg raise maneuver (elevation of the legs), and to determine if these measurements can predict changes in the same as a result of fluid or blood product administration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

The administration of intravenous fluid and blood products for treatment of hypovolemia is common in the ICU setting. Static resuscitation endpoints such as heart rate, blood pressure, and CVP are frequently used to guide this therapy, despite compelling evidence they are unreliable in predicting patient response to therapeutic volume administration or as an endpoint for ongoing therapy. Dynamic parameters such as continuous stroke volume and cardiac output (index) monitoring, along with pulse pressure and stroke volume variance measures are more reliable in predicting and measuring response to fluid challenge and therapeutic volume administration. The purpose of this study is to observe changes in stroke volume (SV) and cardiac output (CO) during a passive leg raise maneuver (PLR) as a surrogate to volume challenge, and to determine if these changes can predict changes in the same parameters with fluid or blood product administration in surgical patients. The PLR maneuver involves positioning the patient to the supine position and elevating the legs to 45 degrees. The PLR moves blood from the capacitance vessels of the legs to the heart, potentially improving stroke volume (SV) and cardiac output (CO), without the administration of intravenous fluids. PLR may predict whether SV or CO would improve with administration of fluids, and guide decisions on whether fluid administration would be beneficial. Stroke volume and cardiac output (index) will be calculated by a commercial pulse power arterial pressure cardiac output system (LIDCORapid), using the patients' measured heart rate and blood pressure imported from the bedside monitor. By using the combination of a reversible volume challenge (PLR) and a minimally invasive monitoring system, it is hoped that a more reliable method will emerge to both predict a response and guide therapeutic volume administration, while reducing the risk associated with fluid volume overload.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years or older admitted to the Surgical Intensive Care Unit, anticipated to receive IV fluid boluses or blood products, with the presence of an arterial pressure line.

Exclusion criteria

  • patients under 18 years of age,
  • pregnancy,
  • prisoners,
  • inability to lay in the supine position,
  • conditions of the lower extremities,
  • pelvis or spine that preclude elevation of the legs

Treatment and study plan

Passive Leg Raise (PLR)

Procedure

From the supine position, the legs are elevated to 45 degrees above the resting surface for a period of 3 minutes. At completion,the legs are lowered to the resting surface.

Primary outcomes

  1. Change in baseline cardiac stroke volume

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Stroke volume is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Stroke volume is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

Secondary outcomes

  1. Change in baseline stroke volume variance (SVV)

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Stroke volume variance is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Stroke volume variance is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

  2. Change in baseline pulse pressure variance (PPV)

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Pulse pressure variance is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Pulse pressure variance is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

  3. Change in baseline cardiac output

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Cardiac output is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Cardiac output is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

  4. Change from baseline heart rate.

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Heart rate is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Heart rate is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

  5. Change in baseline blood pressure (BP)

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Blood pressure is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Blood pressure is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

  6. Change in baseline central venous pressure (CVP).

    Time frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

    Central venous pressure is measured prior to passive leg raise (PLR)and at 3 minutes after completion of the PLR. Central venous pressure is measured at baseline after initiation of fluid/blood administration, every 1 minute for 10 minutes, then every 10 minutes until completion of the administration.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Change in Stroke Volume During Passive Leg Raise Predicts Volume Challenge Response as Measured by Arterial Pressure Cardiac Output Monitor.

Acronym: PVRS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 3, 2012
Registry last updated
Aug 17, 2016

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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