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

NCT03621449 | Withdrawn

• 1 other identifier: RegionSkane ICU 1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Usefulness

  During screening or during examination

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Septic shock according to the sepsis-3 criteria
• 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.
• Hemodynamic monitoring with transpulmonary thermodilution initiated as part of routine clinical monitoring.

You may not qualify if:

• 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).
• PaO2/FiO2 \< 100 mmHg (13.3 kPa) or suspicion of cardiogenic edema
• Transthoracic echo does not allow recording of VTI.
• Age \>18 years.
• No informed consent

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Helsingborg Hospital

Helsingborg, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Peter Bentzer, MD, PhD

  Medical faculty, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: August 8, 2018
• Study Start: September 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

SE (2)