Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality

NCT ID: NCT03630237

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-28

Study Completion Date

2019-10-01

Brief Summary

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The current diagnostic criteria for a heart attack require evaluation of a patient's symptoms and ECG but importantly a blood test called troponin. With advancing technology this test has become more sensitive and is now called a high sensitivity troponin. This is a very effective way of rapidly excluding a heart attack if the test is negative. However there are a number of causes of a raised high sensitivity other than a heart attack, particularly critical illness states. In the absence of features of a heart attack an abnormal result therefore suggests that the heart is inflamed or unwell causing the release of high sensitivity troponin. The DIGNITY study will examine the consequences of high sensitivity troponin elevation in patients in intensive care and assess whether it has a role as a biomarker for predicting outcome.

Detailed Description

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Conditions

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Myocardial Infarction Myocardial Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive care population

All patients admitted to any of the three adult intensive care units (general, cardiac \& neurosciences) at a large teaching hospital. These patients will have a high sensitivity troponin added onto biochemistry samples requested by the clinical team.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients (aged 18 years or older) admitted to any of the three intensive care facilities on site (general, cardiac and neurosciences)
* Biochemistry samples already taken as part of routine clinical care during the ICU stay

Exclusion Criteria

* Patients aged less than 18 years
* No biochemistry samples taken within the ICU stay
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nick Curzen, BM, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

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Univeristy Hospital Southampton

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Jonathan Hinton

Role: CONTACT

0044 (0)2380777222 ext. 3912

Zoe Nicholas

Role: CONTACT

0044 (0)2380777222 ext. 8538

Facility Contacts

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Jonathan Hinton

Role: primary

Zoe Nicholas

Role: backup

Other Identifiers

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RHM CAR0557

Identifier Type: -

Identifier Source: org_study_id

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