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Molecular Diagnosis and Risk Stratification of Sepsis in India

NCT03727243 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2019-01-04

No results posted yet for this study

Summary

Background: Globally, sepsis is common with an estimated population incidence of 437 cases per 100, 000 person-years and acute mortality of 26%, one of the few major medical conditions whose incidence and resulting mortality continues to rise. However, true burden is likely significantly higher as a recent meta- analysis could find no data from LMIC where 87% of the world's population resides.

Objective: Generate new knowledge that will eventually provide rapid and accurate information about an individual patient suffering from sepsis (or critical illness), including which type of microorganism is responsible for the infection and the severity and stage of the patient's immune response.

Methods: MARS-India will be a prospective longitudinal, single-centre observational study, conducted in mixed ICU's of a \>2000 bedded tertiary teaching hospital in Manipal, India. The investigators will recruit to three groups- sex and age-matched healthy volunteers (n=150) and patients diagnosed with sepsis/septic shock or non-infectious ICU admissions such as severe trauma, severe burns and patients admitted to ICU after major surgery (n=400). The investigators have optimised a workflow to follow and describe the immunoinflammatory status of septic patients (as well as severe trauma/burn and major surgery) during the first 6 months after their initial injury. At fixed time points the investigators will collect blood in PaxGene, heparin, citrate and EDTA tubes in addition to routine bloods and microbiological samples. Rectal swabs and stool will also be taken for microbiome analysis. Immune functional tests will be performed to determine whole-blood cytokine/chemokine production in response to ex-vivo stimulation using an 8-panel assay. Additionally, complete immunophenotyping using flow cytometry including HLA-DR expression and lymphocyte subsets will be obtained.

Conditions

  • Sepsis
  • Septic Shock
  • Sepsis Syndrome

Sponsors & Collaborators

  • Kasturba Medical College

    collaborator OTHER

  • BioMérieux

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Chiranjay Mukhopadhyay, MD, Phd · Associate Dean and Professor Department of Microbiology, KMC Manipal

  • Willem Joost Wiersinga, MD, PhD · Professor of Medicine, Chair Devision of Infectious Diseases and head of infectious diseases research group at the centre for experimental and molecular medicine (CEMM), Amsterdam UMC (AMC)

  • Tom van der Poll · Professor of Medicine and Chair department of Medicine, Amsterdam UMC (AMC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2020-07-31
Completion
2021-06-11

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727243 on ClinicalTrials.gov