Predicting Volume Response Study (PVRS)

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

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.

Study Overview

• Status: Completed
• Conditions: Shock; Hypovolemia
• Intervention / Treatment: Procedure: Passive Leg Raise (PLR)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Rhoads 5 SICU on the Trauma/Surgical Critical Service who would be anticipated to receive IV fluids or blood as part of their treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anticipated volume/blood administration; Patients who may receive IV fluid boluses or blood products for restoration of vascular volume. Prior to receiving IV fluid boluses or blood products, the patient will undergo a passive leg raise. (PLR)	Procedure: Passive Leg Raise (PLR); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline cardiac stroke volume	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline stroke volume variance (SVV)	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.
Change in baseline pulse pressure variance (PPV)	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.
Change in baseline cardiac output	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.
Change from baseline heart rate.	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.
Change in baseline blood pressure (BP)	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.
Change in baseline central venous pressure (CVP).	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.	Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: John J Gallagher, MSN, RN, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: central venous pressure; cardiac output; passive leg raise; stroke volume; pulse pressure variance; stroke volume variance; fluid challenge
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 813558