Predicting Volume Response Study

NCT01656954 | Completed

• 1 other identifier: 813558
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Hypovolemia

Keywords

stroke volume; cardiac output; pulse pressure variance; stroke volume variance; passive leg raise; fluid challenge; central venous pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in baseline stroke volume variance (SVV)

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

• Change in baseline pulse pressure variance (PPV)

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

• Change in baseline cardiac output

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

• Change from baseline heart rate.

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

• Change in baseline blood pressure (BP)

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

Study Arms (1)

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)

Interventions

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.

Anticipated volume/blood administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Shock; Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John J Gallagher, MSN, RN

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: August 3, 2012
• Study Start: August 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 17, 2016

Record last verified: 2012-07

Locations

US (1)