Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000685213
Ethics application status
Approved
Date submitted
8/04/2018
Date registered
26/04/2018
Date last updated
26/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
DCD 1010 (PILOT STUDY): Validation Of A Spontaneous Breathing Test To Better Predict Time To Circulatory Death In Organ Donation Candidates (Safety And Feasibility Study)
Scientific title
DCD 1010 (PILOT STUDY): Validation Of A Spontaneous Breathing Test To Better Predict Time To Circulatory Death In Organ Donation Candidates (Safety And Feasibility Study)
Secondary ID [1] 292140 0
Nil Known
Universal Trial Number (UTN)
U1111-1197-5673
Trial acronym
DCD 10-10 Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Drive
 303572 0
Condition category
Condition code
Respiratory 302978 302978 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10 minute spontaneous breathing trial will be performed to assess patient respiratory drive prior to cessation of cardiorespiratory support. This will involve transferring patients from the ventilator to a T-piece device. If breathing rate falls below 10 breaths per minute or oxygen saturations drop by 10% the patient will be reconnected to the ventilator and a positive test result recorded. Otherwise, they will be reconnected to the ventilator after a 10 minute observation period and a negative result recorded
Intervention code [1] 298372 0
Diagnosis / Prognosis
Comparator / control treatment
Sensitivity and specificity of the DCD 10-10 test will be assessed by comparison with Staff Specialist opinion. Staff specialist opinion will be obtained following patient consent for the DCD process. It will be recorded onto the secure RedCap online data collection system and locked prior to the DCD 10-10 test being performed and the outcome of withdrawal of cardiorespiratory support recorded.
Control group
Active

Outcomes
Primary outcome [1] 305434 0
1. To assess the safety of performing a spontaneous breathing trial on a T-piece humidification system for 10 minutes in patients eligible for DCD. This will be done by looking for adverse outcomes in the time surrounding the DCD 10-10 test.
Adverse outcomes to be examined include: ventricular arrhythmia, cardiac arrest, prolonged desaturation (> 5 minutes taken to restore baseline ventilatory settings), severe hypotension (MAP < 60mmHg), failed donation opportunity (inability to continue organ retrieval). Outcomes will be assessed via monitoring at the bedside and documentation into an electronic database by the Organ Donor Coordinator. The rate of events will then be calculated.
Timepoint [1] 305434 0
For the 10 minute duration of the DCD 10-10 test, the 10 minute period following the DCD 10-10 test and the organ donation retrieval process (expected to occur within 1 hour of the DCD 10-10 test)
Primary outcome [2] 305519 0
2. The feasibility of performing the DCD 10-10 test, wit any failure to complete the test recorded.
Timepoint [2] 305519 0
10 minutes following initiation of the DCD 10-10 test
Secondary outcome [1] 345222 0
Sensitivity and specificity of the DCD 10-10 test for predicting death within 90 minutes of cardiorespiratory support.
Timepoint [1] 345222 0
Death within 90 minutes of withdrawal of cardiorespiratory support.
Secondary outcome [2] 345572 0
Comparison of the sensitivity and specificity of the DCD 10-10 test with staff specialist opinion regarding predicted time to death.
Timepoint [2] 345572 0
Death within 90 minutes of cardiorespiratory support.
Secondary outcome [3] 345573 0
Predictive value of BMI. It is predicted that a BMI over > 30 (obesity) will increase the chance of airway obstruction and be a positive predictor of death within 90 minutes.
Timepoint [3] 345573 0
Death within 90 minutes of cardiorespiratory support.
Secondary outcome [4] 345574 0
Predictive value of sedative and analgesic agents. It is predicted that increased dose of sedative and analgesic agents in the hour prior to withdrawal of cardiorespiratory support will be predictive of death within 90 minutes. Data will be recorded on dose of morphine, fentanyl, hydromorphone, buprenorphine, ketamine, midazolam, propofol, diazepam, dexmedetomidine, clonidine. There is also a section on our data form marked 'other' where data on other medications considered to be a vasopressor or ionotrope can be added.
Timepoint [4] 345574 0
The total amount of sedative and analgesic medication administered in the hour prior to withdrawal of cardiorespiratory support and its ability to predict death within 90 minutes.
Secondary outcome [5] 345575 0
Predictive value of ionotrope/vasopressor requirement. It is predicted that increased dose of ionotropes and vasopressors in the hour preceding withdrawal of cardiorespiratory support will be predictive of death within 90 minutes.
Data will be recorded on the dose of Metaraminol, noradrenaline, vasopressin, phenylephrine, angiotensin agonists, dopamine, adrenaline, dobutamine, milrinone, levosimenden. There is also a section on our data form marked 'other' where data on other medications considered to be a vasopressor or ionotrope can be added.
Timepoint [5] 345575 0
The total amount of ionotrope and vasopressor medication administered in the hour prior to withdrawal of cardiorespiratory support and its ability to predict death within 90 minutes.

Eligibility
Key inclusion criteria
All patients who meet the GIVE trigger and have consented for DCD organ donation will be eligible for inclusion in the trial. Therefore, inclusion criteria will include patients whom are mechanically ventilated, with a Glasgow Coma Scale Score < 5, in whom end of life conversations have taken place.

Note: Patient’s receiving a high level of respiratory support (FiO2 > 60%, PEEP > 10) or haemodynamic support (combined vasopressor/ ionotrope requirement > 1microg/kg/min) will be eligible for enrolment in the study and will have all data collected, including Staff Specialist prediction of time to death. It will then be at the Staff Specialists discretion as to whether the DCD 10 – 10 test is necessary to perform.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients less than 18 years of age
- Patients who are pregnant
- Non-ventilated patients
- Patients meeting the criterial for brain death
- Patients screened by the organ donation team, but deemed to be inappropriate for DCD, or whereby the person responsible has not given consent for DCD to proceed
- Inability to gain consent for study enrolment

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive statistics to determine:
- Rate of adverse events
- Consent rate.
- Accuracy of staff specialist opinion
- Correlation of patient variables, such as BMI, to death within 90 minutes
Calculation of sensitivity and specificity of the DCD 10-10 test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/01/2018
Date of last participant enrolment
Anticipated
1/01/2019
Actual
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
70
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 10588 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 10589 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 10590 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 10591 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [5] 10592 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 10593 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [7] 10594 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 10595 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 10596 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [10] 10597 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 22305 0
2305 - New Lambton
Recruitment postcode(s) [2] 22306 0
4870 - Cairns
Recruitment postcode(s) [3] 22307 0
4029 - Herston
Recruitment postcode(s) [4] 22308 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 22309 0
2065 - St Leonards
Recruitment postcode(s) [6] 22310 0
2050 - Camperdown
Recruitment postcode(s) [7] 22311 0
5000 - Adelaide
Recruitment postcode(s) [8] 22312 0
5042 - Bedford Park
Recruitment postcode(s) [9] 22313 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 22314 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 296678 0
Charities/Societies/Foundations
Name [1] 296678 0
John Hunter Hospital Charitable Trust
Country [1] 296678 0
Australia
Primary sponsor type
Individual
Name
Dr Adelaide Charlton
Address
John Hunter Hospital, Lookout Road, New Lambton, NSW 2305
Country
Australia
Secondary sponsor category [1] 295638 0
Individual
Name [1] 295638 0
Dr Jorge Brieva
Address [1] 295638 0
John Hunter Hospital, Lookout Road, New Lambton, NSW 2305
Country [1] 295638 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297906 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297906 0
John Hunter Hospital, Lookout Road, New Lambton, NSW 2305
Ethics committee country [1] 297906 0
Australia
Date submitted for ethics approval [1] 297906 0
17/03/2017
Approval date [1] 297906 0
12/04/2017
Ethics approval number [1] 297906 0
1703/15/4.02

Summary
Brief summary
This study aims to establish a simple, safe, bedside test to better determine which patients are most suitable for organ donation following circulatory death.

The DCD 10-10 test is a 10 minute spontaneous breathing trial which aims to determine respiratory drive in these patients, it is hypothesised that this test will be predictive of which patients will die within 90 minutes post withdrawal of cardiorespiratory support. This 90 minute time frame is essential for ensuring organ viability for donation.

The DCD 10-10 Pilot Study is a safety and feasibility trial on a small sample of patients, it aims to ensure the DCD 10-10 test is safe and can be easily performed in the organ donation setting. It will also test software used for data collection and gather some early descriptive statistics on the sensitivity and specificity of the test and patient factors that correlate to time of death.
Trial website
Trial related presentations / publications
Results will be written up and submitted to the College of Intensive Care Medicine as a trainee formal project. An application for publication in the Journal of Critical Care Medicine will also be made.
Public notes
Attachments [1] 2572 2572 0 0
/AnzctrAttachments/373091-2018.pdf (Protocol)
Attachments [2] 2573 2573 0 0
/AnzctrAttachments/373091(v08-04-2018-09-17-11)-2018.pdf (Participant information/consent)
Attachments [3] 2574 2574 0 0
/AnzctrAttachments/373091-18.pdf (Ethics approval)

Contacts
Principal investigator
Name 75422 0
Dr Adelaide Charlton
Address 75422 0
Intensive Care Unit, John Hunter Hospital, Lookout Road, New Lambton, NSW 2305
Country 75422 0
Australia
Phone 75422 0
+61 417220660
Fax 75422 0
Email 75422 0
[email protected]
Contact person for public queries
Name 75423 0
Dr Adelaide Charlton
Address 75423 0
Intensive Care Unit, John Hunter Hospital, Lookout Road, New Lambton, NSW 2305
Country 75423 0
Australia
Phone 75423 0
+61 417220660
Fax 75423 0
Email 75423 0
[email protected]
Contact person for scientific queries
Name 75424 0
Dr Adelaide Charlton
Address 75424 0
Intensive Care Unit, John Hunter Hospital, Lookout Road, New Lambton, NSW 2305
Country 75424 0
Australia
Phone 75424 0
+61 417220660
Fax 75424 0
Email 75424 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.