Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000935235
Ethics application status
Not yet submitted
Date submitted
29/10/2009
Date registered
2/11/2009
Date last updated
2/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of patient position on liver venous pressure during liver ressection
Scientific title
In patients having a liver resection, does head up positioning, compared to head down or neutral positioning, reduce hepatic venous pressures?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver resection surgery 252082 0
Condition category
Condition code
Surgery 252287 252287 0 0
Surgical techniques
Metabolic and Endocrine 252298 252298 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Changes in position during hepatic resection and its affect on hepatic venous pressure. Positions - 20 degrees head up, flat, 20 degrees head down
Intervention code [1] 241473 0
Other interventions
Comparator / control treatment
The sequence of pressure measurements will alternate in the pattern: Patient 1 - Head up, flat, head down. Patient 2 - Flat, head down, head up. Patient 3 - Head down, head up, flat. And so forth.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253157 0
Hepatic venous pressure - as measured via a 23 gauge cannula inserted into the middle hepatic vein prior to hepatic resection
Timepoint [1] 253157 0
Three measurements in each position (head up, flat, head down). Two minutes will separate each measurement.
Secondary outcome [1] 262056 0
The relationship between hepatic vein pressures and central venous pressures (CVP). Traditionally, CVP is measured and interventions are made to lower this pressure. However, it is the intra-hepatic venous pressure that is more important in preventing blood loss during resection. We will correlated the measured intra-hepatic pressure with the patient's CVP at that time.
Timepoint [1] 262056 0
Each of the three measurements will be compared with the central venous pressure at the time of measurement.

Eligibility
Key inclusion criteria
Elective liver resection patients
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Portal hypertension

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patient will be enrolled during a surgical consultation prior to the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation.
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 2300 0
New Zealand
State/province [1] 2300 0

Funding & Sponsors
Funding source category [1] 243941 0
Hospital
Name [1] 243941 0
Christchurch Hospital
Country [1] 243941 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Riccarton Avenue
Private Bag 4710
Christchurch
Country
New Zealand
Secondary sponsor category [1] 251298 0
None
Name [1] 251298 0
Address [1] 251298 0
Country [1] 251298 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 244056 0
Ethics committee address [1] 244056 0
Ethics committee country [1] 244056 0
Date submitted for ethics approval [1] 244056 0
01/12/2010
Approval date [1] 244056 0
Ethics approval number [1] 244056 0

Summary
Brief summary
Blood loss is a common complication of liver resection surgery. One intervention to reduce this is by lowering central venous pressure (CVP) by having the patient slightly head up. The limitation with this is that it is not CVP that effects blood loss but rather liver venous pressure. Although this is likely to be influenced by a patient's CVP, they are not the same pressure.

We aim to see the relationship between position and hepatic venous pressures (measured by direct cannulation of the middle hepatic vein during surgery) as well as relationship between this pressure and the patient's CVP at the time of measurement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30436 0
Address 30436 0
Country 30436 0
Phone 30436 0
Fax 30436 0
Email 30436 0
Contact person for public queries
Name 13683 0
Dr Russell Clarke
Address 13683 0
Riccarton Avenue
Private Bag 4710
Christchurch
Country 13683 0
New Zealand
Phone 13683 0
+64 210 706 254
Fax 13683 0
Email 13683 0
[email protected]
Contact person for scientific queries
Name 4611 0
Dr Russell Clarke
Address 4611 0
Riccarton Avenue
Private Bag 4710
Christchurch
Country 4611 0
New Zealand
Phone 4611 0
+64 210 706 254
Fax 4611 0
Email 4611 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.