Cardiogenic Shock Registry Mannheim

Cardiogenic Shock Clinical Trial

— CARESMA  

Official title:

Cardiogenic Shock Registry Mannheim - CARESMA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575856
• Other study ID #: 2019-695N
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: Universitätsmedizin Mannheim
• Contact: Michael Behnes, PhD
• Phone: 0049621-3836239
• Email: michael.behnes[@]umm.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register.

Description:

All consecutive patients with a confirmed cardiogenic shock presenting at the internal intensive care Unit (ICU) at the University of Mannheim are included in the register and followed up during ICU stay and after that. Data of patients' admission status, cause of cardiogenic shock, baseline parameters and comorbidities are collected. Extensive information about echocardiography, electrocardiography and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2, 3, 5, 7, and 8). Standard scores for critically ill patients were calculated for the day of admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality and 1-year mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiogenic shock according to current guidelines

Exclusion Criteria:

• other forms of shock not primary associated with cardiac dysfunction

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Germany	First Department of Medicine, University Medical Centre Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	days	30 days
Secondary	all-cause mortality	during hospital stay (up to 30 days)	during hospital stay (up to 30 days)
Secondary	all-cause mortality	years	1 years
Secondary	ventilator-free days	days	30 days