Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT07171918
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2023-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Observational Study to Compare REMS vs NEWS2 for Patients Presenting to the ED With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D014662', 'term': 'Vasoconstrictor Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the utility of REMS score over NEWS2 score - number of days of intensive care.', 'timeFrame': '18 months', 'description': 'To compare REMS score against NEWS2 score with regard to morbidity indicators as - Number of days of intensive care'}, {'measure': 'To determine the utility of REMS score over NEWS2 score - need for vasopressor administration', 'timeFrame': '18 months', 'description': 'To compare REMS score against NEWS2 score with regard to morbidity indicators as - need for vasopressor administration'}, {'measure': 'To determine the utility of REMS score over NEWS2 score - number of days spent as IP', 'timeFrame': '18 months', 'description': 'To compare REMS score against NEWS2 score with regard to morbidity indicators as - number of days spent in hospital'}, {'measure': 'To determine the utility of REMS score over NEWS2 score - need for mechanical ventilation', 'timeFrame': '18 months', 'description': 'To compare REMS score against NEWS2 score with regard to morbidity indicators as - need for mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'To determine in- hospital mortality of patients with clinical suspicion of sepsis', 'timeFrame': '30 days', 'description': 'To compare the effectiveness of REMS and NEWS2 in predicting the in-hospital, 30 day mortality of patients admitted with clinical suspicion of sepsis.'}, {'measure': 'To determine the utility of REMS score over NEWS2 score of patients admitted with qSOFA >/=2', 'timeFrame': '18 months', 'description': 'To compare the utility of REMS score over NEWS2 score for predicting the prognosis of patients admitted with qSOFA \\>/= 2 ; serum lactates \\>/= 2.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nHence comparing REMs against NEWS2 to determine prognostication value of both scores in sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients presenting to ED of Tertiary Care Hospital in Thrissur.\n* Patients age \\>/=18 years\n* Patients who give informed consent for participation in the study.\n* Suspicion of sepsis at the time of presentation to ED as per SSC Guidelines 2021\n\nExclusion Criteria:\n\n* All patients with an alternate diagnosis other than sepsis at the time of discharge.\n* Patients referred from other hospitals with diagnosis of sepsis, after initiation of treatment'}, 'identificationModule': {'nctId': 'NCT07171918', 'briefTitle': 'Prospective Observational Study to Compare REMS vs NEWS2 for Patients Presenting to the ED With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '38/22/IEC/JMMC&RI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis patients', 'interventionNames': ['Drug: Antibiotics, Vasopressors']}], 'interventions': [{'name': 'Antibiotics, Vasopressors', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Sepsis patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thrissur', 'country': 'India', 'facility': 'Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Dr Reshma Haridas', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}