Condition category
Circulatory System
Date applied
10/07/2020
Date assigned
21/07/2020
Last edited
21/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.cmr-berlin.org

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

Publication citations

Additional files

Editorial Notes

10/07/2020: Trial’s existence confirmed by Charité University Medicine Berlin Ethics Board.