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

Septic Shock Clinical Trial

— VIPS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03621449
• Other study ID #: RegionSkane ICU 1
• Status: Withdrawn
• Start date: September 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Skåne University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usefulness	Number of eligible patients in which respective method could not be used	During screening or during examination
Primary	Area under the receiver operator characteristics curve for prediction of fluid responsiveness.	Prediction of fluid responsiveness by evaluation change in cardiac output using either transthoracic ultrasound or calibrated pulse contour analysis after a passive leg raising.	Cardiac output will be measured immediately prior to passive leg raising and 1 minute after completion of passive leg raising
Secondary	Positive and negative likelihood ratios	Prediction of fluid responsiveness by evaluation change in cardiac output using either transthoracic ultrasound or calibrated pulse contour analysis after a passive leg raising.	Cardiac output will be measured immediately prior to passive leg raising and 1 minute after completion of passive leg raising