Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Mortality Among HDU Patients With Modified Early Warning Score Cutoff of 5

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709589
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Bader Faiyaz Zuberi, Dow University of Health Sciences

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Critical Illness Morality Other: Modified Early Warning Score

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of 7th Day All-Cause Mortality Among HDU Patients With Modified Early Warning Score of ≥ 5 With Those With Score of < 5
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : December 6, 2019
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Group-A
Patients with Modified Early Warning Score of ≥ 5
 Other: Modified Early Warning Score
Modified Early Warning Score
Group-B
Patients with Modified Early Warning Score of < 5
 Other: Modified Early Warning Score
Modified Early Warning Score


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mortality [ Time Frame: 7 Days ]
    Status of Alive, Dead or Discharged on 7th Day


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to HDU for any reason
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709589


Locations
Layout table for location information
Pakistan
Ruth KM Pauf Civil Hospital
Karachi, Sindh, Pakistan, 74000
Sponsors and Collaborators
Bader Faiyaz Zuberi
Investigators
Layout table for investigator information
Principal Investigator: Bader F Zuberi, FPCS Dow University of Health Sciences
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Bader Faiyaz Zuberi, Professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT03709589    
Other Study ID Numbers: MEWS-5
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bader Faiyaz Zuberi, Dow University of Health Sciences:
Mortality
High Dependency Unit
Modified Early Warning Score
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes