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

NCT07171918 | Completed

• 1 other identifier: 38/22/IEC/JMMC&RI
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sepsis

Outcome Measures

Primary Outcomes (4)

• 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

  18 months

• 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

  18 months

• 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

  18 months

• 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

  18 months

Secondary Outcomes (2)

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

  30 days

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

  18 months

Study Arms (1)

Sepsis patients

Drug: Antibiotics, Vasopressors

Interventions

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

Sepsis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

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

Thrissur, India

Location

MeSH Terms

Conditions

Sepsis

Interventions

Anti-Bacterial Agents; Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: September 15, 2025
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)