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CompletedNCT07171918Updated Sep 15, 2025

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

An observational study in Sepsis, sponsored by Jubilee Mission Medical College and Research Institute. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Jubilee Mission Medical College and Research Institute · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Sepsis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Based on the sensitivity of REMS score for predicting the morbidity and mortality as compared to NEWS2 in patients with clinical suspicion of sepsis as observed in earlier publications; citing hereby "The utility of the rapid emergency medicine score (REMS) compared with SIRS, qSOFA and NEWS for Predicting in-hospital Mortality among Patients with suspicion of Sepsis in an emergency department" \& "NEWS2 Is Superior to qSOFA in Detecting Sepsis with Organ Dysfunction in the Emergency Department" with 95% confidence level \& 15% relative allowable error, minimum sample size comes to 130.

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
130 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Sepsis patients

    Drug: Antibiotics, Vasopressors

Interventions

  • DrugAntibiotics, Vasopressors

    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

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What researchers measure

Primary outcomes

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

Secondary outcomes

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

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

    Time frame: 30 days

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

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

    Time frame: 18 months

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Study locations

1 site
  • Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute
    Thrissur, India
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07171918
Lead sponsor
Jubilee Mission Medical College and Research Institute
Responsible party
Dr Reshma Haridas (Junior Resident, Jubilee Mission Medical College and Research Institute) — Principal investigator
First posted
Sep 15, 2025
Start date
Jan 1, 2023
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024
Last update
Sep 15, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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