Mannheim Register of Sepsis and Septic Shock (MARSS)

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

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Severe Sepsis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Recruiting
    • First Department of Medicine, University Medical Centre Mannheim
    • Sub-Investigator: Kathrin Weidner, MD
  • Baden Württemberg
    • Mannheim, Baden Württemberg, Germany, 76149
      • Recruiting
      • University Medical Centre Mannheim
      • Contact: Michael Behnes; Phone Number: +496213836239; Email: michael.behnes@umm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes internal medicine patients presenting sepsis and septic shock at the ICU irrespective of the septic focus.

Description

Inclusion Criteria:

• Sepsis and septic shock according to current guidelines

Exclusion Criteria:

• other forms of shock not associated with an infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	in hospital
all-cause mortality	12 months

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock
• Other Study ID Numbers: 2019-694N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No