Clinical trial NCT03917446: Volume Responsiveness Assesment After Propofol.
Official title: Prediction of Volume Responsiveness After Propofol Bolus Injection in the Intensive Care Unit (ICU) Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory Failure
Fluid Volume Disorder
Critical Illness
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated ICU patients with heamodynamic instability aged above 18.

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.

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.

Eligibility criteria: Inclusion Criteria:

ICU patient Haemodynamically instable Mechanically ventilated

Exclusion Criteria:

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

Primary outcomes:
measure: Blood pressure
timeFrame: 10 minutes
measure: Heart rate
timeFrame: 10 minutes
measure: Cardiac output
timeFrame: 10 minutes
measure: Cardiac index
timeFrame: 10 minutes
measure: Stroke volume
timeFrame: 10 minutes
measure: Stroke index
timeFrame: 10 minutes
measure: Stroke volume variation
timeFrame: 10 minutes
measure: Maximum left ventricular contractility (dPmax)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Study officials:
affiliation: Medical University of Gdansk, Faculty of Medicine
name: Jan J Stefaniak, M.D.
role: PRINCIPAL_INVESTIGATOR
References: