Volume Responsiveness Assesment After Propofol.

NCT03917446 | Completed

• 1 other identifier: JS-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients in ICU who suffer from circulatory insufficiency, regardless the cause that require invasive hemodynamic monitoring. The aim of the study is to correlate stroke volume variation which predicts fluid responsiveness with change of the blood pressure after intravenous admission of propofol. This test could become a surrogate of stroke volume variation in patients with contraindications to minimally invasive hemodynamic monitoring.

Conditions

Circulatory Failure; Fluid Volume Disorder; Critical Illness

Outcome Measures

Primary Outcomes (8)

• Blood pressure

  Change in blood pressure values after propofol bolus.

  10 minutes

• Heart rate

  Change in heart rate values after propofol bolus.

  10 minutes

• Cardiac output

  Change in cardiac output values after propofol bolus.

  10 minutes

• Cardiac index

  Change in cardiac index values after propofol bolus.

  10 minutes

• Stroke volume

  Change in stroke volume values after propofol bolus.

  10 minutes

• Stroke index

  Change in stroke index values after propofol bolus.

  10 minutes

• Stroke volume variation

  Change in stroke volume variation values after propofol bolus.

  10 minutes

• Maximum left ventricular contractility (dPmax)

  Change in dPmax values after propofol bolus.

  10 minutes

Study Arms (2)

Euvolaemic

Patients with stroke volume variation less than 8%

Drug: Propofol bolus

Hypovolaemic

Patients with stroke volume variation greater than 13%

Drug: Propofol bolus

Interventions

Propofol bolus DRUG

Each patient gets propofol bolus in three doses. 0.25 mg/kg, 0.5 mg/kg and 1 mg/kg. After each dose patient's blood pressure, heart rate and haemodynamic values calibrated with PICCO device (cardiac output, cardiac index, stroke index, stroke volume, stroke volume variation, dPmax) are recorded in 15 seconds intervals for 10 minutes.

Euvolaemic; Hypovolaemic

Eligibility Criteria

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

Study Population

Mechanically ventilated ICU patients with heamodynamic instability aged above 18.

You may qualify if:

• ICU patient Haemodynamically instable Mechanically ventilated

You may not qualify if:

• Simultaneous propofol infusion Contraindications for propofol Atrial fibrillation Valvular malfunction Aortic stenosis Aortic aneurysm

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, Poland

Location

MeSH Terms

Conditions

Shock; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Jan J Stefaniak, M.D.

  Medical University of Gdansk, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: April 17, 2019
• Study Start: September 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)