- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709589
Comparison of Mortality Among HDU Patients With Modified Early Warning Score Cutoff of 5
Comparison of 7th Day All-Cause Mortality Among HDU Patients With Modified Early Warning Score of ≥ 5 With Those With Score of < 5
Early categorization of critically ill patients by calculating MEWS score in hospitals may give a time window for appropriate steps. If a patient is suffering from sepsis, timely intravenous fluids, early antibiotics and monitoring in a low resource country like Pakistan, may have a great impact. Therefore, the current research is planned to early identify critically ill patients by applying MEWS and reducing the mortality by providing early management and taking appropriate life saving measures.
Objective: To compare frequency of mortality on 7th day of admission in HDU patients with Modified Early Warning Score at the time of admission of < 5 & ≥ 5.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Early recognition and immediate resuscitation are fundamentals of successful management of all critically ill patients if they are suffering from infection and sepsis, malnutrition, AIDS, trauma, diabetes mellitus, drug overdose, and poisoning. In most, seriously ill patients, initial diagnosis may not be clear and immediate objective is to save the life and reverse or prevent vital organ damage e.g. brain, lungs, liver and kidneys. A rapid identifying, low cost method called as Modified Early Warning Score (MEWS) that utilize easy to measure physiological parameters such as vital signs and level of consciousness can be used to identify critical illness, facilitate early intervention and predict mortality. MEWS values range from 0 to maximum 14, higher scores mean greater hemodynamic instability. A score of 5 or more identifies a patient to be critically ill and is associated with increased risk of ICU admission and death. The negative predictive value of early warning MEWS < 3 was 98.1%, indicating the reliability of this score as a screening tool MEWS (modified early warning score) is a reliable screening tool to identify critically ill patients early and to act timely to improve outcomes in health care and prevent adverse events like cardiac arrest, renal failure. A study performed in Uganda on sepsis patients demonstrated that early IV fluid and antibiotic therapy together with vital sign monitoring was associated with lowered 30-day mortality.
Rationale: Early categorization of critically ill patients by calculating MEWS score in hospitals may give a time window for appropriate steps. If a patient is suffering from sepsis, timely intravenous fluids, early antibiotics and monitoring in a low resource country like Pakistan, may have a great impact. Therefore, the current research is planned to early identify critically ill patients by applying MEWS and reducing the mortality by providing early management and taking appropriate life saving measures.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74000
- Ruth KM Pauf Civil Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- admitted in high dependency unit (HDU) of Medical Unit-II
Exclusion Criteria:
- Neurosurgical trauma clinically assessed
- Orthopedics or general surgery trauma patients clinically assessed
- Obstetrics patients clinically assessed
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group-A
Patients with Modified Early Warning Score of ≥ 5
|
Modified Early Warning Score
|
|
Group-B
Patients with Modified Early Warning Score of < 5
|
Modified Early Warning Score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 7 Days
|
Status of Alive, Dead or Discharged on 7th Day
|
7 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bader F Zuberi, FPCS, Dow University of Health Sciences
Publications and helpful links
General Publications
- Mathukia C, Fan W, Vadyak K, Biege C, Krishnamurthy M. Modified Early Warning System improves patient safety and clinical outcomes in an academic community hospital. J Community Hosp Intern Med Perspect. 2015 Apr 1;5(2):26716. doi: 10.3402/jchimp.v5.26716. eCollection 2015.
- Nishijima I, Oyadomari S, Maedomari S, Toma R, Igei C, Kobata S, Koyama J, Tomori R, Kawamitsu N, Yamamoto Y, Tsuchida M, Tokeshi Y, Ikemura R, Miyagi K, Okiyama K, Iha K. Use of a modified early warning score system to reduce the rate of in-hospital cardiac arrest. J Intensive Care. 2016 Feb 9;4:12. doi: 10.1186/s40560-016-0134-7. eCollection 2016.
- van Galen LS, Dijkstra CC, Ludikhuize J, Kramer MH, Nanayakkara PW. A Protocolised Once a Day Modified Early Warning Score (MEWS) Measurement Is an Appropriate Screening Tool for Major Adverse Events in a General Hospital Population. PLoS One. 2016 Aug 5;11(8):e0160811. doi: 10.1371/journal.pone.0160811. eCollection 2016.
- Kruisselbrink R, Kwizera A, Crowther M, Fox-Robichaud A, O'Shea T, Nakibuuka J, Ssinabulya I, Nalyazi J, Bonner A, Devji T, Wong J, Cook D. Modified Early Warning Score (MEWS) Identifies Critical Illness among Ward Patients in a Resource Restricted Setting in Kampala, Uganda: A Prospective Observational Study. PLoS One. 2016 Mar 17;11(3):e0151408. doi: 10.1371/journal.pone.0151408. eCollection 2016.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEWS-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Illness
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruitingDecision Making | Neonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Istituto Clinico HumanitasRecruitingCritical Illness Myopathy | Critical Illness Polyneuropathy | Critical Illness PolyneuromyopathyItaly
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Assistance Publique - Hôpitaux de ParisEuropean Society of Intensive Care Medicine; French Society for Intensive Care and other collaboratorsRecruitingCritical Illness | Intensive Care Patients | Critical Illness Requiring Intensive Care - Sepsis | Critical Illness Requiring Intensive Care - Acute Brain Injury | Critical Illness Requiring Intensive Care - Major Surgery | Critical Illness Requiring Intensive Care - PolytraumaFrance
-
Boston Children's HospitalCompleted
-
Istanbul Medeniyet UniversityRecruiting
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Karolinska InstitutetNot yet recruitingPediatric Critical IllnessSweden
Clinical Trials on Modified Early Warning Score
-
Erzincan UniversityUnknownEarly Warning Score | Early Clinical DeteriorationTurkey
-
Aseer Central HospitalArmed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM); King Khalid...CompletedSepsis | Septic ShockQatar, United Arab Emirates, Turkey, Bahrain, Kuwait, Oman, Saudi Arabia
-
Azienda Ospedaliera Città della Salute e della...Completed
-
Erzincan UniversityUnknown
-
Seoul National University HospitalKorea Health Industry Development Institute; Dong-A University; Inha University... and other collaboratorsNot yet recruitingHospital Rapid Response Team | Hospital Medical Emergency Team
-
University Hospital Carl Gustav CarusCompleted
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyCompleted
-
Brigham and Women's HospitalBiofourmis Inc.CompletedHeart Failure | Chronic Kidney Diseases | Chronic Obstructive Pulmonary Disease | Asthma | Infection | Gout Flare | Hypertensive Urgency | Anticoagulants; Increased | Atrial Fibrillation RapidUnited States
-
Southeast University, ChinaRecruitingHigh-risk Patients | Risk Reduction | Machine LearningChina