Volume Responsiveness Assesment After Propofol.

Completed

• Conditions: Circulatory Failure; Fluid Volume Disorder; Critical Illness
• Interventions: Drug: Propofol bolus

• Registration Number: NCT03917446
• Lead Sponsor: Medical University of Gdansk

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-04-14
• Study First Posted: 2019-04-17
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Euvolaemic	Propofol bolus	Patients with stroke volume variation less than 8%
Hypovolaemic	Propofol bolus	Patients with stroke volume variation greater than 13%

Primary Outcome Measures

Name	Time	Method
Maximum left ventricular contractility (dPmax)	10 minutes	Change in dPmax values after propofol bolus.
Blood pressure	10 minutes	Change in blood pressure values after propofol bolus.
Heart rate	10 minutes	Change in heart rate values after propofol bolus.
Cardiac output	10 minutes	Change in cardiac output values after propofol bolus.
Cardiac index	10 minutes	Change in cardiac index values after propofol bolus.
Stroke volume	10 minutes	Change in stroke volume values after propofol bolus.
Stroke index	10 minutes	Change in stroke index values after propofol bolus.
Stroke volume variation	10 minutes	Change in stroke volume variation values after propofol bolus.

Trial Locations

Locations (1)

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care; 🇵🇱 Gdańsk, Poland