Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001014842
Ethics application status
Approved
Date submitted
18/09/2012
Date registered
20/09/2012
Date last updated
5/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Intraoperative fluid optimization of patients undergoing total hip or knee arthroplasty using pulse pressure variation obtained by a continuous noninvasive blood pressure monitor
Scientific title
The influence of fluid optimization using pulse pressure variation obtained by continuous noninvasive blood pressure monitor compared to standard perioperative pressure driven fluid management in the patients undergoing total hip or knee replacement under general anesthesia on the postoperative morbidity (number and rate of complications and length of stay)
Secondary ID [1] 281245 0
Nil
Universal Trial Number (UTN)
U1111-1134-7595
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perioperative fluid management 287438 0
postoperative morbidity 287439 0
Condition category
Condition code
Anaesthesiology 287774 287774 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fluid optimization guided by the pulse pressure variation obtained by continuous noninvasive arterial pressure monitor (CNAP) based on the volume clamp method in addition to standard pressure/clinical signs based fluid management during the surgical procedure.
Intervention code [1] 285711 0
Treatment: Other
Intervention code [2] 285739 0
Treatment: Devices
Comparator / control treatment
Standard pressure/clinical signs based fluid management
Control group
Active

Outcomes
Primary outcome [1] 288002 0
Rate and number of postoperative infectious and organ complications
Timepoint [1] 288002 0
30 days
Primary outcome [2] 288003 0
Hospital length of stay
Timepoint [2] 288003 0
till discharge
Secondary outcome [1] 299242 0
serum lactate levels assessed by serum assay
Timepoint [1] 299242 0
in the perioperative period (before, immediately after, 4, 8 and 24 hours after surgery)
Secondary outcome [2] 299243 0
perioperative fluid ballance (amount of fluid and blood products administered, urine output and presumed blood loss)
Timepoint [2] 299243 0
throughout the surgery and 24 hrs after

Eligibility
Key inclusion criteria
elective hip or knee arthroplasty, general anesthesia, regular heart rhythm, given and signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
obvious perfusion abnormality on the side of measurement, vascular implants on the side of measurement, known neuronal or neuromuscular disease of upper extremities, peripheral edema

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)
All patients undergoing elective hip or knee arthroplasty in our institution will be deemed eligible for inclusion. During preoperative anesthesia visit the patient meeting inclusion and exclusion criteria will be informed about the possibilities to enter the study. After inclusion the informed consent will be signed. Randomization in 1:1 proportion (stratification to hip / knee arthroplasties) will be performed on the OR by the treating anesthesiologist (member of the research team) - sealed envelopes technique. The randomization sheet will be than marked with the patients identification, sealed again and held concealed till the end of the study. All other members of the team as well as other hospital staff will be unaware of patient allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be performed by random drafting of sealed envelopes containing group allocation (Intervention vs. Control; 1:1 ratio). Stratification to hip and knee group (1:1 ratio).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
As the treating anesthesiologist will provide the intervention he cannot be blinded to the group allocation. All other members and hospital staff will be unaware of the group allocation (partial blinding).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4562 0
Czech Republic
State/province [1] 4562 0

Funding & Sponsors
Funding source category [1] 286022 0
University
Name [1] 286022 0
Charles University Research Fund (project number P36)
Country [1] 286022 0
Czech Republic
Funding source category [2] 286023 0
Commercial sector/Industry
Name [2] 286023 0
CNSystems Medizintechnik AG
Country [2] 286023 0
Austria
Primary sponsor type
University
Name
Dpt. of Anesthesia and Intensive Care of The Faculty of Medicine Plzen - Charles University Prague)
Address
The University hospital and The Faculty of Medicine in Plzen
Charles University Prague
alej Svobody 80
Plzen
304 06
Country
Czech Republic
Secondary sponsor category [1] 284838 0
Individual
Name [1] 284838 0
Jan Benes MD
Address [1] 284838 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Charles University Prague
alej Svobody 80
Plzen
304 06
Country [1] 284838 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288071 0
Local ethics committee of the Charles University hospital in Plzen
Ethics committee address [1] 288071 0
Charles University hospital in Plzen
E. Benese 13
Plzen
305 99
Ethics committee country [1] 288071 0
Czech Republic
Date submitted for ethics approval [1] 288071 0
30/04/2012
Approval date [1] 288071 0
03/05/2012
Ethics approval number [1] 288071 0

Summary
Brief summary
Aim of the trial is to evaluate the possibility of goal-directed fluid therapy during major orthopedic procedures under general anesthesia using protocol based on pulse pressure variation obtained by noninvasive continuous arterial pressure monitoring in comparison to standard usually given care. Influence on the postoperative outcome (number and rate of complications and hospital length of stay) will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34723 0
Address 34723 0
Country 34723 0
Phone 34723 0
Fax 34723 0
Email 34723 0
Contact person for public queries
Name 17970 0
Jan Benes MD
Address 17970 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Charles University Prague
alej Svobody 80
Plzen
304 06
Country 17970 0
Czech Republic
Phone 17970 0
+420377104381
Fax 17970 0
Email 17970 0
benesj@fnplzen.cz
Contact person for scientific queries
Name 8898 0
Assoc.Prof. Eduard Kasal MD, CSc.
Address 8898 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Charles University Prague
alej Svobody 80
Plzen
304 06
Country 8898 0
Czech Republic
Phone 8898 0
+420377104380
Fax 8898 0
Email 8898 0
kasal@fnplzen.cz

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.