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

NCT03630237 | Unknown

• 1 other identifier: RHM CAR0557
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Myocardial Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Distribution of high sensitivity troponin results for different admissions to intensive care

  During intensive care admission

• 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

• Association between high sensitivity troponin results and requirement for inotropic support

  During intensive care admission

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients aged less than 18 years
• No biochemistry samples taken within the ICU stay

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

Univeristy Hospital Southampton

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nick Curzen, BM, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Hinton

CONTACT

0044 (0)2380777222; jonathan.hinton@uhs.nhs.uk

Zoe Nicholas

CONTACT

0044 (0)2380777222; zoe.nicholas@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: January 28, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)