Velocity Time Integral vs PICCO for Evaluation of Passive Leg Raising in Septic Shock (VIPS)

• ClinicalTrials.gov Identifier: NCT03621449
• Recruitment Status: Withdrawn
• First Posted: August 8, 2018
• Last Update Posted: January 11, 2022
• Sponsor: Region Skane
• Information provided by (Responsible Party): Region Skane

Study Description

Brief Summary:

The objective of the present study is to investigate accuracy of changes in cardiac output following passive leg raising as estimated by transthoracic ultrasound as method to predict fluid responsiveness and compare that to changes in cardiac output following PLR as estimated by calibrated pulse contour analysis as method to predict fluid responsiveness in patients with septic shock.

Condition or disease
Septic Shock

Detailed Description:

One method to predict fluid responsiveness is to increase preload by transferring blood from the lower extremities to the central compartment through a passive leg raising (PLR) maneuver and then measure the resulting change in cardiac output. It was recently suggested that an increase in cardiac output following PLR had a high accuracy compared other methods to test fluid responsiveness. Different methods to estimate change in cardiac output have been used in studies investigating accuracy of PLR. Most commonly calibrated pulse contour analysis has been used in mechanically ventilated patients whereas transthoracic echocardiography (TTE)has been used in spontaneously breathing patients. While TTE offers the advantage of being less invasive than calibrated pulse contour analysis it is technically challenging and user dependent and the accuracy of the two methods has not been compared.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Velocity Time Integral vs PICCO for Evaluation of Passive Leg Raising in Septic Shock
• Estimated Study Start Date: September 1, 2021
• Estimated Primary Completion Date: December 30, 2022
• Estimated Study Completion Date: December 30, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Area under the receiver operator characteristics curve for prediction of fluid responsiveness. [ Time Frame: Cardiac output will be measured immediately prior to passive leg raising and 1 minute after completion of passive leg raising ]
   Prediction of fluid responsiveness by evaluation change in cardiac output using either transthoracic ultrasound or calibrated pulse contour analysis after a passive leg raising.

Secondary Outcome Measures :

1. Positive and negative likelihood ratios [ Time Frame: Cardiac output will be measured immediately prior to passive leg raising and 1 minute after completion of passive leg raising ]
   Prediction of fluid responsiveness by evaluation change in cardiac output using either transthoracic ultrasound or calibrated pulse contour analysis after a passive leg raising.

Other Outcome Measures:

1. Usefulness [ Time Frame: During screening or during examination ]
   Number of eligible patients in which respective method could not be used

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients presenting to either of the two study sites a fulfilling inclusion criteria

Criteria

Inclusion Criteria:

1. Septic shock according to the sepsis-3 criteria
2. The treating physician plans to administer fluid to improve organ perfusion and oxygenation due to signs of inadequate organ perfusion and hypoxia (skin mottling, tachycardia (>100), urine output below 0.5 ml/kg/h, lactate persistently > 2 mmol/l and central venous oxygen saturation < 70%, increasing doses of vasoconstrictors to maintain mean arterial pressure >65 mmHg.
3. Hemodynamic monitoring with transpulmonary thermodilution initiated as part of routine clinical monitoring.

Exclusion Criteria:

1. Any condition that will affect the reliability of the PLR procedure or is a contraindication to PLR (compression stockings or intraabdominal pressure > 12 mm Hg, raised intracranial pressure).
2. PaO2/FiO2 < 100 mmHg (13.3 kPa) or suspicion of cardiogenic edema
3. Transthoracic echo does not allow recording of VTI.
4. Age >18 years.
5. No informed consent
6. Prior inclusion in the study

Contacts and Locations

Locations

Sweden

Helsingborg Hospital

Helsingborg, Sweden

Skåne University Hospital

Malmö, Sweden

Sponsors and Collaborators

Region Skane

Investigators

• Principal Investigator: Peter Bentzer, MD, PhD; Medical faculty, Lund University

More Information

• Responsible Party: Region Skane
• ClinicalTrials.gov Identifier: NCT03621449
• Other Study ID Numbers: RegionSkane ICU 1
• First Posted: August 8, 2018
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Skane:

passive leg raising; fluid responsiveness; pulse contour analysis; transthoracic ultrasound; velocity time integral

Additional relevant MeSH terms:

Shock, Septic; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation