SurgeryNCT00942786
Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery?
An observational study of Surgery, run by Medical University of Graz at 1 site in Austria.
Trial summary
The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Surgery
- How many people
- 297 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2008to Feb 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing emergency non-cardiac surgery
Who may be able to join
- Emergency surgery:
- Vascular
- Intra-abdominal
- Orthopedic
Who cannot join
- Patients unable to provide informed consent
- Thoracic surgery
- Trauma surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome
The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events.
Read the detailed description
The purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome.
- Conditions
- Surgery
- Keywords
- natriuretic peptides, emergency non-cardiac surgery
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 |
|---|---|---|
| No treatment | Consecutive patients undergoing emergency surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Adverse Cardiac Events
Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death).
Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality.
Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure.
Measured: postoperatively (index surgery) until a median follow-up of 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Mahla, M.D., Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942786
- Sponsor's protocol ID
- 19-077 ex 07/08
- Status last verified
- Jun 2015
- First submitted
- 18 Jul 2009
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome
- ClinicalTrials.gov ID
- NCT00942786
- Acronym / sponsor ID
- 19-077 ex 07/08
- Conditions
- Surgery
- Keywords
- natriuretic peptides, emergency non-cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Posted 29 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events.
Detailed description
The purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Consecutive patients undergoing emergency surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing emergency non-cardiac surgery
Key inclusion criteria (4 listed)
- Emergency surgery:
Key exclusion criteria (3 listed)
- Patients unable to provide informed consent
- Thoracic surgery
- Trauma surgery
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
Occurence of Adverse Cardiac Events
Time frame: postoperatively (index surgery) until a median follow-up of 34 months
Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death). Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality. Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elisabeth Mahla, M.D. principal investigator
Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz
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 Surgery, run by Medical University of Graz at 1 site in Austria.
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 4 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 29 Jun 2015. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurence of Adverse Cardiac Events (time frame: postoperatively (index surgery) until a median follow-up of 34 months). 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 29 Jun 2015.