ISRCTN ISRCTN11200968
DOI https://doi.org/10.1186/ISRCTN11200968
IRAS number 91553
Secondary identifying numbers 7.0, IRAS 91553
Submission date
24/11/2017
Registration date
11/12/2017
Last edited
24/02/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Jonathan Evans
Public

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

Study information

Study designObservational cross sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet The patient information sheet can be made available on request (email: jonathan.evans@bristol.ac.uk)
Scientific titleCortisol profiles in the critically ill after cardiac surgery
Study acronymCortisol 2
Study objectivesThe 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(s)Frenchay Research Ethics Committee, 10/08/2012, ref: 12/SW/0186
Health condition(s) or problem(s) studiedCritically ill patients following cardiac surgery
InterventionParticipants 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 typeOther
Primary outcome measureCortisol is measured using blood samples taken every ten minutes which will generate a profile over 24 hours.
Secondary outcome measures1. 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 study start date21/03/2012
Completion date30/03/2018

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants20
Total final enrolment20
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/04/2015
Date of final enrolment23/02/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University of Bristol
University/education

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

ROR logo "ROR" https://ror.org/0524sp257

Funders

Funder type

Charity

British Heart Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
the_bhf, The British Heart Foundation, BHF
Location
United Kingdom

Results and Publications

Intention to publish date30/04/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal. The protocol can be made available on request (email: jonathan.evans@bristol.ac.uk).
IPD sharing planOnce analysed, anonymised datasets generated during the current study can be available on request, please contact bristol-cteu@bristol.ac.uk.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2020 24/02/2020 Yes No

Editorial Notes

24/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
3. The IRAS number has been added.