Plain English Summary
Background and study aims
Cardiomyopathy is the name given to a condition that makes it hard for the heart to pump blood effectively. Sepsis occurs when there is an overereation of the body to fight infection with chemicals released into the blood affecting major organs. Sepsis-induced cardiomyopathy (SIC) is a common condition that occurs in 30-50% of patients with severe sepsis and septic shock.
Until today there has been no scientific study on SIC utilizing cardiac MRI. Cardiac MRI represents a unqiue tool with abilities to assess not only cardiac function but also structural changes of the heart muscle such as edema, inflammatory processes and intramyocardial development of cardiac scars.
In this pilot study we want to assess functional and structural changes of the heart muscle in patients with septic shock using cardiac MRI. Results of the analysis could help to understand the mechanism of SIC and to develop clinical strategies to prevent and treat SIC in the future.
Who can participate?
Adult patients with septic shock.
What does the study involve?
All participants receive heart a MRI scan 24-72 hours after their peak of septic shock which is identified by peak dose of blood-pressure elevating norepinephrine medication. All participants receive treatment for their septic shock as usual.
What are the possible benefits and risks of participating?
Participants might benefit from earlier detection of heart problems using MRI compared to alternative routine techniques such as ultrasound. During the MRI scan, participants receive a standard dose of contrast medium that in rare occasions can cause allergic reactions. However, there are no study-associated side effects that exceed those of a regular MRI scan.
Where is the study run from?
HELIOS Hospital Berlin-Buch (Germany)
When is the study starting and how long is it expected to run for?
December 2015 to October 2019
Who is funding the study?
The cost of this study will be funded by the research group itself through university-affiliated research grants. Additionally, grant support has been given by Deutsche Herzstifung e.V. (Grant number F/48/15)
Who is the main contact?
Dr Fabian Muehlberg
Fabian.muehlberg@helios-gesundheit.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fabian Muehlberg
ORCID ID
http://orcid.org/0000-0002-7981-5178
Contact details
HELIOS Hospital Berlin-Buch/Working group Cardiac MRI
Schwanebecker Chaussee 50
Berlin
13125
Germany
+49-30-9401-12988
fabian.muehlberg@helios-gesundheit.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Characterization of critically ill patients with septic shock and sepsis-associated cardiomyopathy using cardiovascular MRI – a pilot study
Acronym
CISS
Study hypothesis
Severe bacterial infections can affect the entire human body, which is called sepsis. It is known that these infections can also affect the function of the heart. In this study we hypothesized that changes of the heart muscle structure such as edema and inflammation can be detected in these critically ill patients using cardiovascular MRI. In detail, we hypothesized that myocardial T2 times are elevated in patients with severe sepsis.
Ethics approval
Approved 08/12/2015, Charité University Medicine Berlin Ethics Board (Ethikommission Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany; +49-30-450 517 222; ethikkommission@charite.de), ref: EA1/311/15
Study design
Observational cohort 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 contact details to request a participant information sheet.
Condition
Sepsis-associated cardiomyopathy in septic shock
Intervention
Participants receive one cardiac MRI during septic shock, specifically between 24 and 72 hours after peak dose of norepinephrine. MRI protocol includes cardiac function assessment using cine imaging and myocardial tissue differentiation using native T1 and T2 mapping as well as the contrast-enhanced techniques late gadolinium enhancement and extracellular volume quantification. Additionally, follow-up cardiac ultrasounds are performed 48 and 96 hours after the MRI scan.
Intervention type
Device
Phase
Drug names
1. Cardiac MRI
2. Cardia ultrasound
Primary outcome measure
Mean myocardial T2 time measured using MRI at 24-72 hours after peak of norepinephrine
Secondary outcome measures
1. Left ventricular ejection fraction measured using MRI at 24-72 hours after peak of norepinephrine
2. Myocardial T1 time measured using MRI at 24-72 hours after peak of norepinephrine
3. Right ventricular ejection fraction measured using MRI at 24-72 hours after peak of norepinephrine
4. Left ventricular ejection fraction measured using echocardiography at 48 and 96hours after the MRI scan
5. Late gadolinium enhancement measured using MRI at 24-72 hours after peak of norepinephrine
Overall trial start date
08/12/2015
Overall trial end date
31/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Septic shock requiring catecholamine treatment despite sufficient fluid resuscitation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Total final enrolment
15
Participant exclusion criteria
1. Any absolute contraindication for MRI
2. Chronic renal failure with GFR < 30 ml/min/m² at time of inclusion (with the exception of patients on dialysis)
3. Myocardial infarction < 6 months before inclusion
4. Previously known LVEF < 40% at inclusion
Recruitment start date
01/04/2016
Recruitment end date
31/08/2019
Locations
Countries of recruitment
Germany
Trial participating centre
HELIOS Hospital Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany
Sponsor information
Organisation
Helios Hospital Berlin-Buch
Sponsor details
Charité Berlin-Buch/HELIOS Hospital Berlin-Buch
Lindenberger Weg 80
Berlin
13125
Germany
+49-30-9401-12939
jeanette.schulz-menger@charite.de
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Deutsche Herzstiftung e.V.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are intending to publish at least one research article in a high-ranking peer-reviewed journal, such as JCMR (impact factor 5.1)
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to reasons of data protection laws in Germany. However, upon request methodology and data set structure can be shared.
Intention to publish date
31/12/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list