Condition category
Circulatory System
Date applied
24/11/2017
Date assigned
11/12/2017
Last edited
30/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cortisol is a steroid that the body produces naturally. It is normally produced in a ‘diurnal rhythm’. This means that its levels change throughout the day. When people are healthy, there are high levels in the morning and low levels at about 4pm (this is why you feel awake in the morning and sleepy in the late afternoon). Pulses coming from your brain generate this rhythm; there are lots of big pulses in the morning and fewer, smaller pulses in the late afternoon. It is not known what happens to these pulses when people are unwell after heart surgery. However, we think it is important to know what happens to these pulses because steroids help protect the body from large stressors (of which heart surgery is one). We think that people who do not produce enough steroid when they are on the intensive care unit do not do as well (they stay on the intensive care unit longer and need more medicines to help keep their blood pressure up). On the other hand, too much steroid causes its own side effects such as poor wound healing and short-term diabetes. The aim of this study measures what actually happens to patients’ pulses of cortisol. This may help clinicians to work out who needs extra, or if we are giving more than we need to. It has been shown that these pulses change dramatically when a patient is chronically unwell and early results from current work we are doing shows large derangements in those having routine cardiac surgery. This study is designed to see what happens to these pulses when people are critically ill. Once we know what is ‘normal’ during critical illness, we can begin to give steroids to patients in a more tailored way.

Who can participate?
Males aged 18 to 80 who are undergoing cardiac surgery.

What does the study involve?
Patients who took part in the study had small blood samples (0.7 – 2mls) every ten minutes for 24 hours from the tubes that are already in place. There are no extra needles and the total volume of blood we take is less than a tea-cup.

What are the possible benefits and risks of participating?
There were no direct benefits to those taking part. There was also little risk taking part as only small blood samples were being taken.

Where is the study run from?
Bristol Royal Infirmary (UK)

When is the study starting and how long is it expected to run for?
March 2012- March 2018

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
Mr Jonathan Evans

Trial website

Contact information

Type

Public

Primary contact

Mr Jonathan Evans

ORCID ID

Contact details

Clinical Trials Evaluation Unit
Level 7
Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7.0

Study information

Scientific title

Cortisol profiles in the critically ill after cardiac surgery

Acronym

Cortisol 2

Study hypothesis

The aim of this study is to investigate what happens to cortisol pulses when people are critically ill. Once we know what is ‘normal’ during critical illness, we can begin to give steroids to patients in a more tailored way.

Ethics approval

Frenchay Research Ethics Committee, 10/08/2012, ref: 12/SW/0186

Study design

Observational cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

The patient information sheet can be made available on request (email: jonathan.evans@bristol.ac.uk)

Condition

Critically ill patients following cardiac surgery

Intervention

Participants undergo blood sampling for 24 hours via their in situ lines from 8am in the morning. Cortisol sampling of 0.7ml is taken every 10 minutes. Blood sampling for ACTH occurs at hourly intervals (1ml for each ACTH sample). CBG sampling occus at time points 0 and 24hrs (2ml). Inflammatory mediator sampling (1ml) occurs at four hourly intervals. Total blood volume sampled does not exceed 150mls.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Cortisol is measured using blood samples taken every ten minutes which will generate a profile over 24 hours.

Secondary outcome measures

1. Adreno-corticotrophic hormone is measured using blood samples taken at hourly intervals
2. Cortisol Binding Globulin (CBG) is measured using blood samples taken at baseline and 24 hours
3. Inflammatory mediators are measured using blood samples taken at every four hours

Overall trial start date

21/03/2012

Overall trial end date

30/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consultee of opinion that patient would consent
2. Male
3. Ages 18 – 80 undergoing cardiac surgery
4. At least 2 of the following on day 2 or later post cardiac surgery:
4.1. Ventilation
4.2. Concurrent use of inotropes and/or vasopressors
4.3. Haemo(dia)filtration

Participant type

Other

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Consultee of opinion that patient would not consent
2. Current or recent (within 3 months) use of glucocorticoids
3. Disorders of the HPA axis
4. Thyroid disease
5. Etomidate use at any stage of the surgical pathway

Recruitment start date

20/04/2015

Recruitment end date

23/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
University Hospitals Bristol NHS Foundation Trust Upper Maudlin St
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

RED
3rd Floor
Senate House
Tyndall Ave
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. The protocol can be made available on request (email: jonathan.evans@bristol.ac.uk).

IPD sharing statement:
Once analysed, anonymised datasets generated during the current study can be available on request, please contact bristol-cteu@bristol.ac.uk.

Intention to publish date

30/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes