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

• Conditions: Myocardial Injury; Myocardial Infarction

• Registration Number: NCT03630237
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2019-01-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital	During intensive care admission

Secondary Outcome Measures

Name	Time	Method
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	Distribution of high sensitivity troponin results in; * Medical admissions; * Trauma / emergency surgical admissions; * Planned surgical admissions; * Post cardiac surgical patients; * Neurosurgical patients
Association between high sensitivity troponin results and requirement for inotropic support	During intensive care admission

Trial Locations

Locations (1)

Univeristy Hospital Southampton; 🇬🇧 Southampton, United Kingdom