Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05836285




Registration number
NCT05836285
Ethics application status
Date submitted
18/04/2023
Date registered
1/05/2023
Date last updated
1/05/2023

Titles & IDs
Public title
The ARRC III Trial of Advanced Recovery Room Care (ARRC). A Pilot Registry at RAH
Scientific title
The ARRC III Trial of Advanced Recovery Room Care (ARRC). A Pilot Registry at RAH
Secondary ID [1] 0 0
17557
Universal Trial Number (UTN)
Trial acronym
ARRCIII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Surgical Complication 0 0
Economic Problems 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days at Home after surgery
Timepoint [1] 0 0
90 days after surgery
Secondary outcome [1] 0 0
in-hospital complications
Timepoint [1] 0 0
out to 10 days after surgery
Secondary outcome [2] 0 0
mortality
Timepoint [2] 0 0
12 months after surgery
Secondary outcome [3] 0 0
cost-effectiveness
Timepoint [3] 0 0
90 days after surgery

Eligibility
Key inclusion criteria
Scheduled for elective or unplanned surgery at Royal Adelaide Hospital Scheduled to stay in
hospital at least one night after surgery 30-day mortality of 0.5% to 8% by the US National
Safety and Quality Improvement Program risk score (NSQIP)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing cardiac surgery Scheduled for postoperative Intensive Care Unit management

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort
study of approximately 850 patients, to produce a marked improvement in patient and hospital
outcomes, and hospital costs, in medium risk patients (in press).

The goal of this observational study is to examine the outcomes after non-cardiac surgery of
a larger group of medium risk patients receiving different forms of care -ARRC and usual ward
care. The main questions it aims to answer are:

what are the outcomes for patients and hospital after the different forms of care, who
receives benefit from high acuity care, what underlies the improved outcomes seen with high
acuity care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05836285
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Guy Ludbrook, MBBS PhD
Address 0 0
Professor of Anaesthesia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Guy L Ludbrook, MBBS PhD
Address 0 0
Country 0 0
Phone 0 0
+61 413817901
Fax 0 0
Email 0 0
guy.ludbrook@sa.gov.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05836285