NCT03709589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

October 15, 2018

Last Update Submit

August 17, 2021

Conditions

Critical IllnessMorality

Keywords

MortalityHigh Dependency UnitModified Early Warning Score

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Status of Alive, Dead or Discharged on 7th Day

    7 Days

Study Arms (2)

Group-A

Patients with Modified Early Warning Score of ≥ 5

Other: Modified Early Warning Score

Group-B

Patients with Modified Early Warning Score of \< 5

Other: Modified Early Warning Score

Interventions

Modified Early Warning ScoreOTHER

Modified Early Warning Score

Group-AGroup-B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to HDU for any reason

You may qualify if:

  • admitted in high dependency unit (HDU) of Medical Unit-II

You may not qualify if:

  • Neurosurgical trauma clinically assessed
  • Orthopedics or general surgery trauma patients clinically assessed
  • Obstetrics patients clinically assessed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruth KM Pauf Civil Hospital

Karachi, Sindh, 74000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 25846353BACKGROUND

  • 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.

    PMID: 26865981RESULT

  • 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.

    PMID: 27494719RESULT

  • 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.

    PMID: 26986466RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bader F Zuberi, FPCS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 17, 2018

Study Start

December 6, 2018

Primary Completion

November 5, 2019

Study Completion

December 6, 2019

Last Updated

August 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)