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Clinical Trials/NCT03630237
NCT03630237
Unknown
Not Applicable

Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality. The DIGNITY Study

University Hospital Southampton NHS Foundation Trust1 site in 1 country1,500 target enrollmentJanuary 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrollment
1500
Locations
1
Primary Endpoint
Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 28, 2019
End Date
October 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital

Time Frame: During intensive care admission

Secondary Outcomes

  • Association between high sensitivity troponin results and duration of ventilation(Within twenty eight days)
  • Association between high sensitivity troponin results and length of intensive care admission(Number of days not in intensive care within twenty eight days of original intensive care admission)
  • Distribution of high sensitivity troponin results for different admissions to intensive care(During intensive care admission)
  • Association between high sensitivity troponin results and requirement for inotropic support(During intensive care admission)

Study Sites (1)

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