Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001218987
Ethics application status
Approved
Date submitted
14/09/2020
Date registered
16/11/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Is preoperative psoas muscle size and/or postoperative vasopressor-intrope drug dosages associated with outcomes after heart and/or lung transplantation
Scientific title
Psoas Muscle Size and Postoperative Vasopressor-Inotrope Score as a predictor of outcomes in heart and/or lung transplant patients
Secondary ID [1] 302302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart transplantation 319055 0
Lung transplantation 319056 0
Condition category
Condition code
Surgery 317009 317009 0 0
Other surgery
Musculoskeletal 317386 317386 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective observational cohort study using patient medical records to investigate whether preoperative psoas muscle size measured on CT scans and/or the vasopressor-intotrope score predict postoperative outcomes after heart and/or lung transplantation. Records from patients transplanted at St Vincent’s Hospital, Sydney from 1st January 2016 to 30th September 2020 will be accessed
Intervention code [1] 318593 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325118 0
Hospital Length of Stay as determined from patient medical records
Timepoint [1] 325118 0
Date of Hospital Discharge
Secondary outcome [1] 386914 0
Length of Intensive Care Stay as determined from patient medical records
Timepoint [1] 386914 0
Discharge from Intensive Care
Secondary outcome [2] 386915 0
6 month Survival status as determined from patient medical records and outpatient clinic notes
Timepoint [2] 386915 0
6 months post-transplantation date
Secondary outcome [3] 386916 0
Duration of mechanical ventilation as determined from patient medical records
Timepoint [3] 386916 0
Time of Extubation
Secondary outcome [4] 386917 0
30-day mortality as determined from patients medical records and outpatient clinic notes
Timepoint [4] 386917 0
30 days post-transplantation
Secondary outcome [5] 388912 0
Psoas Muscle Cross Sectional Area
Timepoint [5] 388912 0
Preoperative CT scan performed during transplantation work up

Eligibility
Key inclusion criteria
Heart and/or Lung Transplantation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306727 0
Hospital
Name [1] 306727 0
St Vincent’s Hospital, Sydney
Country [1] 306727 0
Australia
Primary sponsor type
Individual
Name
Erez Ben-Menachem
Address
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria St,
Darlinghurst,
NSW 2010
Country
Australia
Secondary sponsor category [1] 307278 0
None
Name [1] 307278 0
N/A
Address [1] 307278 0
N/A
Country [1] 307278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306899 0
St Vincent’s Hospital. Sydney Human Research and Ethics Committee
Ethics committee address [1] 306899 0
390 Victoria St,
Darlinghurst,
NSW 2010
Ethics committee country [1] 306899 0
Australia
Date submitted for ethics approval [1] 306899 0
31/08/2020
Approval date [1] 306899 0
17/09/2020
Ethics approval number [1] 306899 0
2020/ETH02249

Summary
Brief summary
A retrospective cohort study will review patient records to calculate a vasoactive-inotropic score for patients who have undergone heart and/or lung transplantation. Additionally in those patients who have has an abdominal CT scan in the preoperative period a psoas muscle cross sectional area (PMCSA) will be calculated. The objective is to assess the association between the VIS and the PMCSA
and whether either measure is associated with post-operative outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105386 0
Dr Erez Ben-Menachem
Address 105386 0
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria Rd,
Darlinghurst, NSW 2010
Country 105386 0
Australia
Phone 105386 0
+61 2 83823200
Fax 105386 0
Email 105386 0
Erezben@yahoo.com
Contact person for public queries
Name 105387 0
Erez Ben-Menachem
Address 105387 0
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria Rd,
Darlinghurst, NSW 2010
Country 105387 0
Australia
Phone 105387 0
+61 2 83823200
Fax 105387 0
Email 105387 0
Erezben@yahoo.com
Contact person for scientific queries
Name 105388 0
Erez Ben-Menachem
Address 105388 0
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria Rd,
Darlinghurst, NSW 2010
Country 105388 0
Australia
Phone 105388 0
+61 2 83823200
Fax 105388 0
Email 105388 0
Erezben@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient privacy and consent does not extend to IPD sharing


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.