Predicting Volume Response Study

NCT ID: NCT01656954

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-04-30

Brief 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.

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.

Conditions

Shock; Hypovolemia

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Passive Leg Raise (PLR)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John J Gallagher, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

813558

Identifier Type: -

Identifier Source: org_study_id