Characterization of critically ill patients with severe bacterial infections using cardiovascular MRI

ISRCTN ISRCTN85297773
DOI https://doi.org/10.1186/ISRCTN85297773
Submission date
10/07/2020
Registration date
21/07/2020
Last edited
23/05/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Fabian Muehlberg
Scientific

HELIOS Hospital Berlin-Buch/Working group Cardiac MRI
Schwanebecker Chaussee 50
Berlin
13125
Germany

ORCiD logoORCID ID 0000-0002-7981-5178
Phone +49-30-9401-12988
Email fabian.muehlberg@helios-gesundheit.de

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleCharacterization of critically ill patients with septic shock and sepsis-associated cardiomyopathy using cardiovascular MRI – a pilot study
Study acronymCISS
Study objectivesSevere 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(s)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
Health condition(s) or problem(s) studiedSepsis-associated cardiomyopathy in septic shock
InterventionParticipants 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)1. Cardiac MRI 2. Cardia ultrasound
Primary outcome measureMean myocardial T2 time measured using MRI at 24-72 hours after peak of norepinephrine
Secondary outcome measures1. 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 study start date08/12/2015
Completion date31/10/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15
Total final enrolment15
Key inclusion criteriaSeptic shock requiring catecholamine treatment despite sufficient fluid resuscitation
Key exclusion criteria1. 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
Date of first enrolment01/04/2016
Date of final enrolment31/08/2019

Locations

Countries of recruitment

  • Germany

Study participating centre

HELIOS Hospital Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany

Sponsor information

Helios Hospital Berlin-Buch
University/education

Charité Berlin-Buch/HELIOS Hospital Berlin-Buch
Lindenberger Weg 80
Berlin
13125
Germany

Phone +49-30-9401-12939
Email jeanette.schulz-menger@charite.de
Website http://www.cmr-berlin.org
ROR logo "ROR" https://ror.org/05hgh1g19

Funders

Funder type

Other

Investigator initiated and funded

No information available

Deutsche Herzstiftung e.V.

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planWe 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 19/05/2022 23/05/2022 Yes No

Editorial Notes

23/05/2022: Publication reference added.
10/07/2020: Trial’s existence confirmed by Charité University Medicine Berlin Ethics Board.