Critical IllnessNCT03709589
Comparison of Mortality Among HDU Patients With Modified Early Warning Score Cutoff of 5
An observational study of Critical Illness and Morality, run by Bader Faiyaz Zuberi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Morality
- What is being tested?
- Modified Early Warning Score
- How many people
- 145 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Dec 2018to 6 Dec 2019
- 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: All patients admitted to HDU for any reason
Who may be able to join
- admitted in high dependency unit (HDU) of Medical Unit-II
Who cannot join
- Neurosurgical trauma clinically assessed
- Orthopedics or general surgery trauma patients clinically assessed
- Obstetrics patients clinically assessed
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Critical Illness, Morality
- Being tested
- Modified Early Warning Score
- Keywords
- Mortality, High Dependency Unit, Modified Early Warning Score
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Early Warning ScoreOther
Modified Early Warning Score
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Patients with Modified Early Warning Score of ≥ 5 Receives: Other: Modified Early Warning Score | |
| Group-B | Patients with Modified Early Warning Score of < 5 Receives: Other: Modified Early Warning Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Status of Alive, Dead or Discharged on 7th Day
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start6 Dec 2018
- Primary completion5 Nov 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bader Faiyaz Zuberi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bader Faiyaz Zuberi, Dow University of Health Sciences
- Investigators
- Bader F Zuberi, FPCS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709589
- Sponsor's protocol ID
- MEWS-5
- Status last verified
- Aug 2021
- First submitted
- 15 Oct 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25846353Nishijima 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.
PubMed 26865981van 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.
PubMed 27494719Kruisselbrink 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.
PubMed 26986466
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03709589
- Acronym / sponsor ID
- MEWS-5
- Conditions
- Critical Illness, Morality
- Keywords
- Mortality, High Dependency Unit, Modified Early Warning Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Bader Faiyaz ZuberiUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 17 Oct 2018 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | – | Other: Modified Early Warning ScorePatients with Modified Early Warning Score of ≥ 5 |
| Group-B | – | Other: Modified Early Warning ScorePatients with Modified Early Warning Score of < 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to HDU for any reason
Key inclusion criteria (1 listed)
- admitted in high dependency unit (HDU) of Medical Unit-II
Key exclusion criteria (3 listed)
- Neurosurgical trauma clinically assessed
- Orthopedics or general surgery trauma patients clinically assessed
- Obstetrics patients clinically assessed
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 |
|---|---|---|
| Modified Early Warning ScoreModified Early Warning Score | Other | Group-A, Group-B |
Primary outcome
Mortality
Time frame: 7 Days
Status of Alive, Dead or Discharged on 7th Day
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 23 Aug 2021.
- Background: PubMed 25846353Mathukia 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.
- Results publication: PubMed 26865981Nishijima 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.
- Results publication: PubMed 27494719van 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.
- Results publication: PubMed 26986466Kruisselbrink 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.
- 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.
Bader F Zuberi, FPCS principal investigator
Dow University of Health Sciences
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 Critical Illness and Morality, run by Bader Faiyaz Zuberi at 1 site in Pakistan.
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 1 inclusion and 3 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 23 Aug 2021. 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 Pakistan. 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?
Mortality (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709589, which also lists 4 linked publications.
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 23 Aug 2021.