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NCT Number: NCT07171918

Prospective Observational Study to Compare REMS vs NEWS2 for Patients Presenting to the ED With Sepsis

Prospective observational study to determine the utility of Rapid Emergency Medicine Score (REMS) in comparison to National Early Warning Score2 (NEWS2) for predicting morbidity and mortality among patients presenting to the Emergency Department with clinical suspicion of Sepsis

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute

Thrissur, India

About this study

Rapid Emergency Medicine Score (REMS) is an attenuated version of the Acute Physiology and Chronic Health Evaluation (APACHE) II score and has utility in predicting mortality in non- surgical patients. The NEWS2 can be used on all hospitalized patients to allow for the early detection of clinical deterioration and potential need for higher level of care. NEWS2 is closely associated with sepsis, however REMS is not so. But in recent studies comparing other EWS (Early Warning Scores) of sepsis, REMS was found to be superior.

Hence comparing REMs against NEWS2 to determine prognostication value of both scores in sepsis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presenting to ED of Tertiary Care Hospital in Thrissur.
  • Patients age >/=18 years
  • Patients who give informed consent for participation in the study.
  • Suspicion of sepsis at the time of presentation to ED as per SSC Guidelines 2021

Exclusion criteria

  • All patients with an alternate diagnosis other than sepsis at the time of discharge.
  • Patients referred from other hospitals with diagnosis of sepsis, after initiation of treatment

Treatment and study plan

Antibiotics, Vasopressors

Drug

Both groups are scored on REMS and NEWS2, and then observed closely for the period of hospital stay with regard to ICU stay duration, ventilator days, vasopressor dependent days and total hospital duration

Primary outcomes

  1. To determine the utility of REMS score over NEWS2 score - number of days of intensive care.

    Time frame: 18 months

    To compare REMS score against NEWS2 score with regard to morbidity indicators as - Number of days of intensive care

  2. To determine the utility of REMS score over NEWS2 score - need for vasopressor administration

    Time frame: 18 months

    To compare REMS score against NEWS2 score with regard to morbidity indicators as - need for vasopressor administration

  3. To determine the utility of REMS score over NEWS2 score - number of days spent as IP

    Time frame: 18 months

    To compare REMS score against NEWS2 score with regard to morbidity indicators as - number of days spent in hospital

  4. To determine the utility of REMS score over NEWS2 score - need for mechanical ventilation

    Time frame: 18 months

    To compare REMS score against NEWS2 score with regard to morbidity indicators as - need for mechanical ventilation

Secondary outcomes

  1. To determine in- hospital mortality of patients with clinical suspicion of sepsis

    Time frame: 30 days

    To compare the effectiveness of REMS and NEWS2 in predicting the in-hospital, 30 day mortality of patients admitted with clinical suspicion of sepsis.

  2. To determine the utility of REMS score over NEWS2 score of patients admitted with qSOFA >/=2

    Time frame: 18 months

    To compare the utility of REMS score over NEWS2 score for predicting the prognosis of patients admitted with qSOFA >/= 2 ; serum lactates >/= 2.

Sponsors and collaborators

Lead sponsor

Jubilee Mission Medical College and Research Institute

Other

Registry information

Official study title

Prospective Observational Study to Determine the Utility of REMS in Comparison to NEWS2 for Predicting Morbidity and Mortality Among Patients Presenting to the ED Suspicion of Sepsis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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