SepsisNCT07171918
Prospective Observational Study to Compare REMS vs NEWS2 for Patients Presenting to the ED With Sepsis
An observational study of Sepsis, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Antibiotics, Vasopressors
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2023to 31 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute
Thrissur
About this study
Official 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
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.
- Conditions
- Sepsis
- Being tested
- Antibiotics, Vasopressors
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics, VasopressorsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Sepsis patients | Not described Receives: Drug: Antibiotics, Vasopressors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 30 days
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Reshma Haridas, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171918
- Sponsor's protocol ID
- 38/22/IEC/JMMC&RI
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07171918
- Acronym / sponsor ID
- 38/22/IEC/JMMC&RI
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis patients | – | Drug: Antibiotics, Vasopressors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics, VasopressorsBoth 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 | Drug | Sepsis patients |
Primary outcome
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
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
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
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
2 secondary outcomes
To determine in- hospital mortality of patients with clinical suspicion of sepsis
Time frame: 30 days
To determine the utility of REMS score over NEWS2 score of patients admitted with qSOFA >/=2
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the utility of REMS score over NEWS2 score - number of days of intensive care. (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.