Mannheim Register of Sepsis and Septic Shock

Septic Shock Clinical Trial

— MARSS  

Official title:

Mannheim Register of Sepsis and Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231720
• Other study ID #: 2019-694N
• Status: Recruiting
• Start date: December 3, 2019
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• 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 sepsis and septic shock within a monocentric observational clinical register.

Description:

All consecutive septic patients at the internists intensive care Unit (ICU) at the University of Mannheim are included in the register and follow up during ICU stay and after that. Data of patients' admission status, septic focus, 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 10). Standard scores for critically ill patients were calculated for the day before 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 septic patients' 1-year mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Sepsis and septic shock according to current guidelines

Exclusion Criteria:

• other forms of shock not associated with an infection

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

Locations

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

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		30 days
Secondary	all-cause mortality		in hospital
Secondary	all-cause mortality		12 months