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

Withdrawn

• Conditions: Septic Shock

• Registration Number: NCT03621449
• Lead Sponsor: Region Skane

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.

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 Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-08
• Study Start: 2021-09-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the receiver operator characteristics curve for prediction of fluid responsiveness.	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

Name	Time	Method
Positive and negative likelihood ratios	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.

Trial Locations

Locations (2)

Skåne University Hospital; 🇸🇪 Malmö, Sweden

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden