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Completed

NCT Number: NCT03917446

Volume Responsiveness Assesment After Propofol.

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.

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Key information

Conditions

Circulatory Failure Critical Illness Disease Attributes Fluid Volume Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ICU patient Haemodynamically instable Mechanically ventilated

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Blood pressure

    Time frame: 10 minutes

    Change in blood pressure values after propofol bolus.

  2. Heart rate

    Time frame: 10 minutes

    Change in heart rate values after propofol bolus.

  3. Cardiac output

    Time frame: 10 minutes

    Change in cardiac output values after propofol bolus.

  4. Cardiac index

    Time frame: 10 minutes

    Change in cardiac index values after propofol bolus.

  5. Stroke volume

    Time frame: 10 minutes

    Change in stroke volume values after propofol bolus.

  6. Stroke index

    Time frame: 10 minutes

    Change in stroke index values after propofol bolus.

  7. Stroke volume variation

    Time frame: 10 minutes

    Change in stroke volume variation values after propofol bolus.

  8. Maximum left ventricular contractility (dPmax)

    Time frame: 10 minutes

    Change in dPmax values after propofol bolus.

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2019
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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