Clinical trial NCT03621449: Velocity Time Integral vs PICCO for Evaluation of Passive Leg Raising in Septic Shock
Official title: Velocity Time Integral vs PICCO for Evaluation of Passive Leg Raising in Septic Shock
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Septic Shock
Keywords: passive leg raising
fluid responsiveness
pulse contour analysis
transthoracic ultrasound
velocity time integral
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to either of the two study sites a fulfilling inclusion criteria

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.

Eligibility 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

Primary outcomes:
measure: Area under the receiver operator characteristics curve for prediction of fluid responsiveness.
timeFrame: Cardiac output will be measured immediately prior to passive leg raising and 1 minute after completion of passive leg raising
Secondary outcomes:
measure: Positive and negative likelihood ratios
timeFrame: Cardiac output will be measured immediately prior to passive leg raising and 1 minute after completion of passive leg raising
Other outcomes:
measure: Usefulness
timeFrame: During screening or during examination
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Medical faculty, Lund University
name: Peter Bentzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: