Predicting Volume Response Study (PVRS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
John Gallagher, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01656954
First received: July 17, 2012
Last updated: August 2, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Shock
Hypovolemia
Procedure: Passive Leg Raise (PLR)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Change in Stroke Volume During Passive Leg Raise Predicts Volume Challenge Response as Measured by Arterial Pressure Cardiac Output Monitor.

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in baseline cardiac stroke volume [ Time Frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • Change in baseline cardiac output [ Time Frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration. ] [ Designated as safety issue: No ]
    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.

  • Change from baseline heart rate. [ Time Frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration. ] [ Designated as safety issue: No ]
    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.

  • Change in baseline blood pressure (BP) [ Time Frame: Passive Leg Raise: Baseline and at 3 minutes. Fluid/blood administration: Baseline to completion of administration. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

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

Criteria

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
  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: NCT01656954

Contacts
Contact: John J Gallagher, MSN, RN 215-459-2026 john.gallagher@uphs.upenn.edu
Contact: Joy Steele, BSN, RN 267-971-0021 joy.steele@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: John J Gallagher, MSN, RN    215-459-2026    john.gallagher@uphs.upenn.edu   
Contact: Joy Steele, BSN, RN    267-971-0021    joy.steele@uphs.upenn.edu   
Principal Investigator: John J Gallagher, MSN, RN         
Sponsors and Collaborators
University of Pennsylvania
Covidien
Investigators
Principal Investigator: John J Gallagher, MSN, RN University of Pennsylvania
  More Information

No publications provided

Responsible Party: John Gallagher, Trauma Program Manager, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01656954     History of Changes
Other Study ID Numbers: 813558
Study First Received: July 17, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
stroke volume
cardiac output
pulse pressure variance
stroke volume variance
passive leg raise
fluid challenge
central venous pressure

Additional relevant MeSH terms:
Shock
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014