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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
01

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

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's enrollment of 130 is below the median of 150 across 1,162 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients presenting to ED of Tertiary Care Hospital in Thrissur.
  • Patients age >/=18 years
  • Patients who give 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Jun 2024, 17 months.

Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's 17 months is below that.

Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2023
First posted
Sep 15, 2025
StartActual
Jan 1, 2023
Primary completionActual
Jun 30, 2024
CompletionActual
Dec 31, 2024
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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 ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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