Predicting Volume Response Study

Shock Clinical Trial

— PVRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656954
• Other study ID #: 813558
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: August 15, 2016
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypovolemia
• Shock

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No