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Trial registered on ANZCTR


Registration number
ACTRN12611001107910
Ethics application status
Approved
Date submitted
19/10/2011
Date registered
24/10/2011
Date last updated
24/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Randomized Cross-over Study of Two Mean Arterial Pressure Targets During and Immediately After Cardiac Surgery
Scientific title
A Pilot Randomized Cross-over Study of The Effects of Two Mean Arterial Pressure Targets During and Immediately After Cardiac Surgery on Hepatic Vein Oxygen Saturation.
Secondary ID [1] 273234 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac surgery 278995 0
Condition category
Condition code
Anaesthesiology 279177 279177 0 0
Anaesthetics
Cardiovascular 279206 279206 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Increase in mean arterial pressure with intravenous noradrenaline infusion.
Noradrenaline will be infused through a central venous catheter at th enecessary dose to achieve and maintain a MAP 20 mmHg grater than baseline for 30 minutes while the patient is on cardiopulmonary bypass and for 2 hours after the patient is returned to ICU.

The noradrenaline infusion will then be decreased after such period and the patient returned to baseline levels.
This cross over will have no washout period.
After the noradrenaline infusion, patients will then be immediately crossed over to the standard care arm,
Intervention code [1] 269565 0
Treatment: Drugs
Comparator / control treatment
Standard care.
This involves invasive monitoring of blood pressure, cardiac output and central venous pressure and administration of drugs and fluids to maintain a mean arterial pressure of 60-70 mmHg. This will occur during cardiopulmonary bypass in the period before and after the intervention.
Standard care will also be delivered after cardiopulmonary bypass in the period after cessation of intervention and will continue as clinically indicated thereafter.
Control group
Active

Outcomes
Primary outcome [1] 279815 0
Hepatic vein oxygen saturation.
This is measured by the insertion of curved catehter from the femoral vein guided by X-ray into the hepatic vein.
The catheter can be used to obtain blood form the hepatic vein which is the then taken to a blood gas machine, where arterial blood gases and oxygen saturation can be measured.
Timepoint [1] 279815 0
each 2 hours of intervention
Secondary outcome [1] 294502 0
Level of cytokines.

The blood levels of interleukin 6, interleukin-10 and tumour necrosis factor will be measured by ELISA techniques in blood obtained form the radial artery cannula and from the hepatic vein cannula.
Timepoint [1] 294502 0
each 2 hours of intervention

Eligibility
Key inclusion criteria
Open heart cardiac surgery
Ability to insert a hepatic venin cannula
Informed consent
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to insert hepatic vein catheter
Emergency surgery
Severe disorder of coagulation
Lack of informed consent
Jeovah's witness
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random numbers and sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270063 0
Hospital
Name [1] 270063 0
Austin Hospital Anaesthesia & Intensive Care Trust Fund
Address [1] 270063 0
Austin Hospital
Studley Rd
Heidelberg, Vic 3084
Country [1] 270063 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Austin Hospital
Studley Rd
Heidelberg, Vic 3084
Country
Australia
Secondary sponsor category [1] 269026 0
None
Name [1] 269026 0
Address [1] 269026 0
Country [1] 269026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272019 0
Austin Hospital Human research Ethics Committee
Ethics committee address [1] 272019 0
Austin Hospital
Studley Rd
Heidelberg, Vic 3084
Ethics committee country [1] 272019 0
Australia
Date submitted for ethics approval [1] 272019 0
Approval date [1] 272019 0
01/01/1999
Ethics approval number [1] 272019 0
H99/00667

Summary
Brief summary
Samll pilot cross over study comparing two differen tmean arterial pressures in patient having cardiac surgery
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 33282 0
Address 33282 0
Country 33282 0
Phone 33282 0
Fax 33282 0
Email 33282 0
Contact person for public queries
Name 16529 0
Rinaldo Bellomo
Address 16529 0
Austin Hospital
Studley Rd
Heidelberg, Vic 3084
Country 16529 0
Australia
Phone 16529 0
+61394965992
Fax 16529 0
+61394963932
Email 16529 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 7457 0
Rinaldo Bellomo
Address 7457 0
Austin Hospital
Studley Rd
Heidelberg, Vic 3084
Country 7457 0
Australia
Phone 7457 0
+61394965992
Fax 7457 0
+61394963932
Email 7457 0
rinaldo.bellomo@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary