Molecular Diagnosis and Risk Stratification of Sepsis (MARS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborators:
Center for Translational Molecular Medicine
UMC Utrecht
Radboud University
Philips Healthcare
Microbiome
Immunetrics
Check-Points
Biocartis
ImmuneXpress
Information provided by (Responsible Party):
T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01905033
First received: July 11, 2013
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools available to the clinician to initiate therapy of patients with sepsis mainly comprise of symptom classification systems and culture techniques, which provide aspecific and slow information.

Objective: The ultimate goal of this program is to assist the physician at the bedside in tailoring the treatment of an individual patient suffering from sepsis by generating rapid molecular information about the causative pathogen and the host response.

Deliverables: Rapid tests ("sample-in-result-out") that can be used by health care personnel at or close to the bedside and that provide rapid information (within two hours) about the presence or absence of sepsis, the causative pathogen and the risk of the individual patient for sepsis complications and death.

Design: The program is organized into four Work Packages (WPs) along a clinical, discovery and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from these patients will be used to develop rapid, fully automated DNA-based bedside tests that identify microorganisms and also provide information about their resistance to antibiotics. In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and to develop rapid and easy to perform tests that provide information about the risk profile of the patient. In addition, plasma levels of selected protein biomarkers will be measured for comparison of their value with that of the identified leukocyte molecular signatures. WP4 is responsible for the ICT management of the project. The Clinical Platform (covered by WP1 and WP4) delivers patient data and biological samples to the discovery and technology platforms. The Discovery Platform (covered by WP2 and WP3) uses patient data and biological samples to develop tests for detection of the infectious agent causing sepsis and for stratification of patients according to their risk for sepsis complications, including death. The results generated within the discovery platform will be delivered to the technology platform. The Technology Platform (part of WP2 and WP3) has the specific aim to develop rapid assays that run on a fully automated (micro)fluidics platform that is so easy to operate that it can be used in decentralized settings such as (close to) the ICU. The developed assays will make use of the knowledge generated in the discovery platform.


Condition
Sepsis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Molecular Diagnosis and Risk Stratification of Sepsis

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Molecular information about causative pathogens and the host response in patients with sepsis [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stratification of septic patients by severity and type of immune response to infection [ Time Frame: Five years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, plasma, RNA, DNA.


Estimated Enrollment: 7500
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In 3-4 years all patients> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht will be included in the study with the exemption of elective cardiac surgery patients with an uncomplicated stay.

Criteria

Inclusion Criteria:

  • All patients> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht.

Exclusion Criteria:

  • Elective cardiac surgery patients with an uncomplicated stay.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905033

Contacts
Contact: Tom van der Poll, Prof. +31205665910 t.vanderpoll@amc.uva.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Tom van der Poll, Prof.         
Principal Investigator: Tom van der Poll, Prof.         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Marc J Bonten, Prof.       mbonten@umcutrecht.nl   
Principal Investigator: Marc J. Bonten, Prof.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Center for Translational Molecular Medicine
UMC Utrecht
Radboud University
Philips Healthcare
Microbiome
Immunetrics
Check-Points
Biocartis
ImmuneXpress
Investigators
Principal Investigator: Tom van der Poll, Prof. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: T. van der Poll, Prof. dr. T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01905033     History of Changes
Other Study ID Numbers: 10-056
Study First Received: July 11, 2013
Last Updated: August 21, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Sepsis
Pneumonia
Peritonitis
Biomarkers
Transcriptomics
Pathogen detection

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014