Volume Responsiveness Assesment After Propofol.

Prediction of Volume Responsiveness After Propofol Bolus Injection in the Intensive Care Unit (ICU) Patients.

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Circulatory Failure; Fluid Volume Disorder
• Intervention / Treatment: Drug: Propofol bolus

Detailed Description

This prospective, observational study was conducted after approval of the Independent Bioethics Commitee at Medical University of Gdańsk (numer zgody) and registered in ClinicalTrials.gov. Mechanically ventilated patients of intensive care unit who routinely recieved haemodynamic monitoring with PiCCO™ (Getinge AB, Sweden) technology using Philips IntelliVue PiCCO-Module (Philips Healthcare, Amsterdam, Netherlands), were enrolled. Patients were sedated with midazolam infusion at 0,15 to 0,6 mg kg-1 h-1 . Before the trial in each patient, heart rate (HR) invasive (IBP) and non - invasive blood pressure, (NIBP) infusion rate of catecholamines and non adrenergic vasopressors was recorded and PiCCO device was callibrated by transpulmonary thermodilution with 20 ml of cold saline. Global end diastolic volume (GEDV), intrathoracic blood volume (ITBV) and stroke volume variation (SVV) were calculated and recorded. For effective ventilation with increased tidal volume of 8 ml kg-1 of Predicted Body Weight, each patient recieved propofol bolus of 0,25 mg kg-1, 0,5 mg kg-1 and 1,0 mg kg-1 consecutively. Higher doses were used at good tolerance of the lower ones. After each bolus systolic and diastolic invasive blood pressure, heart rate (HR), continuous cardiac output (CCO), continuous cardiac index (CCI), stroke volume index (SI), stroke volume variantion (SVV), and left ventricular contractility index (dPmax) were recorded every fifteen seconds for ten minutes. The absolute and realtive change in blood pressure, compared to the values of blood pressure before the drug administration, were correlated with SVV. Time interval between each examination ranged from 4 to 48 hours.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated ICU patients with heamodynamic instability aged above 18.

Description

Inclusion Criteria:

ICU patient Haemodynamically instable Mechanically ventilated

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Euvolaemic; Patients with stroke volume variation less than 8%	Drug: Propofol bolus; 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.
Hypovolaemic; Patients with stroke volume variation greater than 13%	Drug: Propofol bolus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Jan J Stefaniak, M.D., Medical University of Gdansk, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: April 14, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Shock; Critical Illness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: JS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No