Death, Sudden,CardiacNCT01214460
Impact of Medical Emergency Team and EMS in Tampere University Hospital
An observational study of Death, Sudden,Cardiac, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes like cardiac arrest or transfer to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden,Cardiac
- How many people
- 10,000 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2010to 26 Sep 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 adult EMS or in-hospital patients with deteriorating vital signs or patients in risk in Tampere University Hospital
Who may be able to join
- 18 yrs or older
Who cannot join
- under 18 yrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Medical Emergency Team and EMS on ICU Readmissions and Sudden Cardiac Arrests in Tampere University Hospital
Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes like cardiac arrest or transfer to intensive care unit. The aims of this study are to record and analyze the effects of EMS and department of emergency and both afferent and efferent limbs of MET activity in Finnish tertiary Hospital.
- Conditions
- Death, Sudden,Cardiac
- Keywords
- MET
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All MET calls | We make an Utstein type analyze to all MET calls | |
| All EMS calls | We make an Utstein type analyze to all EMS calls during June 2015 | |
| All patient in the emergency department | We make an Utstein type analyze to all Emergency visits during June 2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: patients are followed until death
Secondary outcomes (4)
The rates of ICU readmissions
Measured: one month to six year
The rates of DNAR orders
Measured: one month to six year
The number of patients EMS or medical emergency team is called to treat
We are going to analyze the number of MET calls and their impact on sudden cardiac arrests in TAUH. The time frame is 1st Jan 2010 -31st Dec 2015. It is known fact that well working MET team inside the hospital should decrease the sudden cardiac arrests. We also analyze the EMS calls and the ED visits in June 2015 to see if patient detoriation is related to sudden in-hospital death.
Measured: one month to six years
Patient mortality after 6 mo of discharge
The patients are followed 6 mo after hospital discharge which has happened in year 2010
Measured: one month to six year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2016
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death, Sudden,CardiacStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jari Kalliomäki, MD, Principal investigator, Tampere University HospitalSanna Hoppu, MD, PhD, Principal investigator, Tampere University HospitalJoonas Tirkkonen, MD, Principal investigator, Tampere University HospitalTimo Kontula, MD, Principal investigator, Tampere University HospitalEetu Loisa, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214460
- Sponsor's protocol ID
- R10111
- Status last verified
- Sep 2019
- First submitted
- 5 Jul 2010
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medical Emergency Team and EMS on ICU Readmissions and Sudden Cardiac Arrests in Tampere University Hospital
- ClinicalTrials.gov ID
- NCT01214460
- Acronym / sponsor ID
- R10111
- Conditions
- Death, Sudden,Cardiac
- Keywords
- MET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 5 Oct 2010 (estimated)
- 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.
Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes like cardiac arrest or transfer to intensive care unit. The aims of this study are to record and analyze the effects of EMS and department of emergency and both afferent and efferent limbs of MET activity in Finnish tertiary Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All MET calls | – | –We make an Utstein type analyze to all MET calls |
| All EMS calls | – | –We make an Utstein type analyze to all EMS calls during June 2015 |
| All patient in the emergency department | – | –We make an Utstein type analyze to all Emergency visits during June 2015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult EMS or in-hospital patients with deteriorating vital signs or patients in risk in Tampere University Hospital
Key inclusion criteria (1 listed)
- 18 yrs or older
Key exclusion criteria (1 listed)
- under 18 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: patients are followed until death
4 secondary outcomes
The rates of ICU readmissions
Time frame: one month to six year
The rates of DNAR orders
Time frame: one month to six year
The number of patients EMS or medical emergency team is called to treat
Time frame: one month to six years
Patient mortality after 6 mo of discharge
Time frame: one month to six year
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 27 Sep 2019.
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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.
Jari Kalliomäki, MD principal investigator
Tampere University Hospital
Sanna Hoppu, MD, PhD principal investigator
Tampere University Hospital
Joonas Tirkkonen, MD principal investigator
Tampere University Hospital
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 Death, Sudden,Cardiac, run by Tampere University Hospital at 1 site in Finland.
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 1 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 27 Sep 2019. 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 Finland. 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?
In-hospital mortality (time frame: patients are followed until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.