Characterization of critically ill patients with severe bacterial infections using cardiovascular MRI
| ISRCTN | ISRCTN85297773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85297773 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Helios Hospital Berlin-Buch |
| Funders | Investigator initiated and funded, Deutsche Herzstiftung e.V. |
- 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
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
Scientific
HELIOS Hospital Berlin-Buch/Working group Cardiac MRI
Schwanebecker Chaussee 50
Berlin
13125
Germany
 ORCID ID |
0000-0002-7981-5178 |
|---|---|
| Phone | +49-30-9401-12988 |
| fabian.muehlberg@helios-gesundheit.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Characterization of critically ill patients with septic shock and sepsis-associated cardiomyopathy using cardiovascular MRI – a pilot study |
| Study acronym | CISS |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | 1. Cardiac MRI 2. Cardia ultrasound |
| Primary outcome measure(s) |
Mean myocardial T2 time measured using MRI at 24-72 hours after peak of norepinephrine |
| Key secondary outcome measure(s) |
1. Left ventricular ejection fraction measured using MRI at 24-72 hours after peak of norepinephrine |
| Completion date | 31/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 15 |
| Total final enrolment | 15 |
| Key inclusion criteria | Septic shock requiring catecholamine treatment despite sufficient fluid resuscitation |
| Key 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 |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 31/08/2019 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/05/2022 | 23/05/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2022: Publication reference added.
10/07/2020: Trial’s existence confirmed by Charité University Medicine Berlin Ethics Board.
