Plain English Summary
Background and study aims
Delirium is a state of mental confusion that affects up to 80% of mechanically ventilated ICU patients. It is associated with prolonged ICU and hospital stay, the development of cognitive impairment and increased mortality (death rate). Therefore, early detection of delirious patients is essential for treatment. After delirium is diagnosed, the main aim is to reduce its severity and duration. Dexmedetomidine is one of the drugs which are suggested for the prevention and treatment of delirious ICU patients. The aim of this study is to investigate its possible side-effects on blood circulation using single transpulmonary thermodilution and pulse contour analysis - techniques to measure blood flow which are routinely used in ICU patients.
Who can participate?
Critically ill patients aged 18 and older with delirium after admission to the ICU
What does the study involve?
All participants are treated with dexmedetomidine. Dexmedetomidine is part of the normal routine care for ICU patients with delirium. After 2 hours the dose is increased. Blood flow measurements (transpulmonary thermodilution and pulse contour analysis) are performed at 0, 2 and 4 hours after starting dexmedetomidine treatment. When the delirium has resolved and there is no need for further monitoring or treatment on the ICU, the participants are transferred to a normal ward.
What are the possible benefits and risks of participating?
Transpulmonary thermodilution and pulse contour analysis are used to analyse the effects of dexmedetomidine and improve treatment monitoring. Only patients already equipped with the PiCCO heart output monitor are chosen for this study. These are patients in whom heart and blood volume monitoring is necessary (e.g. sepsis, acute respiratory distress syndrome, acute pancreatitis, burns, etc.). Therefore there are no additional risks due to the placing of catheters. As soon a local or systemic infection is suspected, the catheters are removed.
Where is the study run from?
Technical University of Munich (Germany)
When is the study starting and how long is it expected to run for?
January 2016 to August 2017
Who is funding the study?
Technical University of Munich (Germany)
Who is the main contact?
1. Dr Alexander Herner
2. Prof. Wolfgang Huber
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alexander Herner
ORCID ID
http://orcid.org/0000-0003-3905-9280
Contact details
Klinik und Poliklinik für Innere Medizin II
Klinikum rechts der Isar der TU München
Ismaningerstr. 22
Munich
81675
Germany
Type
Scientific
Additional contact
Prof Wolfgang Huber
ORCID ID
Contact details
Klinik und Poliklinik für Innere Medizin II
Klinikum rechts der Isar der TU München
Ismaningerstr. 22
Munich
81675
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DEX
Study information
Scientific title
Influence of dexmedetomidine on hemodynamic parameters in critical ill patients with delirium: a single center prospective study
Acronym
Study hypothesis
Dexmedetomidine infuences cardiac performance.
Ethics approval
Fakultät für Medizin, Technische Universität München, 26/06/2012, ref: 5384/12s
Study design
Prospective observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Critically ill patients with occurring delirium after admission to ICU
Intervention
Twelve consecutive ICU patients with agitated delirium according to Richmond Agitation Sedation Scale (RASS) were assigned to receive dexmedetomidine (DEX). Dexmedetomidine is part of the normal routine care for ICU-patients with delirium. According to the manufacturer's suggestion DEX was administered initially at 0.3µg/kg/h. After 2h the dosage of DEX was increased to 0.7µg/kg/h to achieve RASS-levels between -2 and 0. Hemodynamic measurements (transpulmonary thermodilution and pulse contour analysis) were performed 0h, 2h and 4h after initiation of DEX. In case of the pre-defined stopping criteria (MAP<65mmHg and/or HR<60/min) DEX was stopped. In this case hemodynamic measurements were performed immediately after stopping of DEX and 2h after withdrawal. There was no loading dose of DEX. After resolution of delirium and no need for further monitoring or treatment on the ICU, the patients are transferred to a normal ward. Further interviews or observations are not planned.
Intervention type
Drug
Phase
Not Applicable
Drug names
Dexmedetomidine
Primary outcome measure
Cardiac power index is measured using the transpulmonary thermodilution technique (PiCCO) at the individual maximum dosage of dexmedetomidine (0.3µg/kg/h or 0.7µg/kg/h) and compared to baseline values (dexmedetomidine, 0 µg/kg/h)
Secondary outcome measures
1. Cardiac index (CI) is measured using the transpulmonary thermodilution technique (PiCCO)
2. Systemic vascular resistance index (SVRI) is measured using the transpulmonary thermodilution technique (PiCCO)
3. Global end diastolic volume index (GEDVI) is measured using the transpulmonary thermodilution technique (PiCCO)
4. Extravascular lung water index (EVLWI) is measured using the transpulmonary thermodilution technique (PiCCO)
5. Pulmonary vascular permeability index (PVPI) is measured using the transpulmonary thermodilution technique (PiCCO)
6. Heart rate (HR) is measured permanently via 5-French thermistor tipped arterial catheter
7. Mean arterial pressure (MAP) is measured permanently via 5-French thermistor tipped arterial catheter
Transpulmonary thermodilution measurements were performed at following timepoints and concentrations:
0h: dexmedetomidine: 0 µg/kg/h
2h: dexmedetomidine: 0.3µg/kg/h
4h: dexmedetomidine: 0.7µg/kg/h
2h after therapy with dexmedetomidine was stopped
or as soon as predefined termination criteria (HR <60/min and/or MAP<65mmHg) were fulfilled
Overall trial start date
01/01/2016
Overall trial end date
01/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Critically ill patients (18 years and older) with occurring delirium after admission to ICU. For delirium screening the Confusion Assessment Method (CAM-ICU) and Richmond Agitation-Sedation-Scale (RASS) were used.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
In total 12 patients were included in this study
Participant exclusion criteria
1. Younger than 18 years
2. Pregnancy
3. Known drug intolerance or allergy against dexmedetomidine
4. Increased intracranial pressure
5. Patients with cerebrale pathology, which changes the controllability of sedation or die consciousness
6. Myasthenia Gravis
7. Cerebellar or spinal Ataxia
8. Enzyme related disorders that are associated with a severe decreased activity of UDP-glucoronyltransferase (e.g. M. Crigler- Najjar)
9. Chronic liver insufficiency CHILD A, B or C
Recruitment start date
01/02/2016
Recruitment end date
30/09/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Technical University of Munich
Intensive care unit, II. Medical Department
Ismaningerstr. 22
Munich
81675
Germany
Funders
Funder type
University/education
Funder name
Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar der TU München
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Additional documents (such as study protocol, statistical analysis plan) are/will be available upon request from Alexander Herner and Wolfgang Huber. Planned publication of results in a peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Alexander Herner and Wolfgang Huber.
Intention to publish date
01/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list