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

July 4, 2019 updated by: University Hospital Southampton NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During intensive care admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of high sensitivity troponin results for different admissions to intensive care
Time Frame: 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
During intensive care admission
Association between high sensitivity troponin results and duration of ventilation
Time Frame: Within twenty eight days
Within twenty eight days
Association between high sensitivity troponin results and length of intensive care admission
Time Frame: Number of days not in intensive care within twenty eight days of original 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
Time Frame: During intensive care admission
During intensive care admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Investigators

  • Principal Investigator: Nick Curzen, BM, PhD, University Hospital Southampton NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2019

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (ACTUAL)

August 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM CAR0557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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