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Volume Responsiveness Assesment After Propofol.

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ClinicalTrials.gov Identifier: NCT03917446
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk

Brief Summary:
Patients in ICU who suffer from circulatory insufficiency, regardless

Condition or disease Intervention/treatment
Circulatory Failure Fluid Volume Disorder Critical Illness Drug: Propofol bolus

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Prediction of Volume Responsiveness After Propofol Bolus Injection in the Intensive Care Unit (ICU) Patients.
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Group/Cohort Intervention/treatment
Euvolaemic 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 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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated ICU patients with heamodynamic instability aged above 18.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917446


Contacts
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Contact: Jan J Stefaniak, M.D. +48583493270 j.stefaniak@gumed.edu.pl

Locations
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Poland
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care Recruiting
Gdańsk, Poland
Contact: Jan J Stefaniak, M.D.    +48583493270    klanest@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
Investigators
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Principal Investigator: Jan J Stefaniak, M.D. Medical University of Gdansk, Faculty of Medicine

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Responsible Party: Radoslaw Owczuk, Professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT03917446     History of Changes
Other Study ID Numbers: JS-1
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Critical Illness
Shock
Disease Attributes
Pathologic Processes
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics