Clinical trial NCT03630237: Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality
Official title: Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality. The DIGNITY Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Myocardial Injury
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted any of the three adult intensive care units at a large teaching hospital that have at least one biochemistry sample performed as part of their routine care

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital
timeFrame: During intensive care admission
Secondary outcomes:
measure: Distribution of high sensitivity troponin results for different admissions to intensive care
timeFrame: During intensive care admission
measure: Association between high sensitivity troponin results and duration of ventilation
timeFrame: Within twenty eight days
measure: Association between high sensitivity troponin results and length of intensive care admission
timeFrame: Number of days not in intensive care within twenty eight days of original intensive care admission
measure: Association between high sensitivity troponin results and requirement for inotropic support
timeFrame: During intensive care admission
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Univeristy Hospital Southampton
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Nick Curzen, BM, PhD
role: PRINCIPAL_INVESTIGATOR
References: