Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000456853
Ethics application status
Approved
Date submitted
19/04/2012
Date registered
24/04/2012
Date last updated
19/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Usefulness of pulse pressure variation and stroke volume variation as predictive factors for fluid responsiveness in patients with pneumoperitoneum
Scientific title
Usefulness of pulse pressure variation and stroke volume variation as predictive factors for fluid responsiveness in patients with pneumoperitoneum
Secondary ID [1] 280319 0
Nil
Universal Trial Number (UTN)
U1111-1129-9414
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Predictive value of dynamic indicators of fluid responsiveness (pulse pressure variation and stroke volume variation) in pneumoperitoneum 286281 0
Condition category
Condition code
Cardiovascular 286508 286508 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of our study is to investigate whether Pulse Pressure Variation (PPV) and Stroke Volume Variation (SVV) can be used as reliable predictors of fluid responsiveness in patients with pneumoperitoneum. Patients undergoing laparoscopic abdominal surgery will be included in the study. Standard operative monitoring (pulse oximetry, arterial blood pressure, electrocardiogram) as well as a LiDCO Rapid monitor (LiDCO Ltd, Cambridge, UK) will be connected. After induction of anaesthesia, the mechanical ventilation will be commenced with the tidal volume set to at least 8ml/kg IBW. Immediately after commencing mechanical ventilation and applying maintenance dose of an anaesthetic, values of SVV, PPV, nCI (non-calibrated cardiac index) and nSI (non-calibrated stroke index) will be recorded for baseline values. The first fluid challenge will then take place. For the purpose of this study, a standard fluid challenge will consist of a bolus of 3ml/kg of body weight of a colloid solution (balanced electrolyte solution of hydroxyethyl starch, Volulyte [Registered Trademark], Fresenius Kabi AG, Bad Homburg, Germany) given intravenously in 5 minutes or less. The aforementioned set of variables will always be recorded immediately prior to fluid challenge and at 5 minutes. The same fluid challenge will be repeated on the same patient in the setting of a stable pneumoperitoneum. Stable pneumoperitoneum will be achieved using an automated system for laparoscopic surgery. The intraabdominal pressure is set to 10-15mmHg and is automatically sustained. The pressure rises at insuflation and then stabilises at the set value. The absolute value of pneumoperitoneum is not crucial for the study, it is however important, that the pressure remains stable during a fluid challenge.
Intervention code [1] 284673 0
Not applicable
Comparator / control treatment
No control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286943 0
Increase in stroke volume index after a fluid challenge of 10% or more will be sought. Such patients will be classified as responders.
Timepoint [1] 286943 0
At 5 minutes after starting a fluid challenge.
Secondary outcome [1] 297037 0
Nil
Timepoint [1] 297037 0
Nil

Eligibility
Key inclusion criteria
Adult patients undergoing laparoscopic abdominal procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cardiac arrhythmias.
Patients with spontaneous breathing activity.
Patients with IAH before laparoscopy.
Patients with severe aortic regurgitation.
Pregnant women.
Non-adults.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2012
Actual
22/01/2013
Date of last participant enrolment
Anticipated
31/03/2017
Actual
30/09/2016
Date of last data collection
Anticipated
31/03/2017
Actual
30/09/2016
Sample size
Target
40
Accrual to date
Final
77
Recruitment outside Australia
Country [1] 4257 0
Slovenia
State/province [1] 4257 0

Funding & Sponsors
Funding source category [1] 285087 0
Hospital
Name [1] 285087 0
University Medical Centre Ljubljana
Country [1] 285087 0
Slovenia
Primary sponsor type
Hospital
Name
University Medical Centre Ljubljana
Address
Zaloska 7
1000 Ljubljana
Country
Slovenia
Secondary sponsor category [1] 283952 0
None
Name [1] 283952 0
Address [1] 283952 0
Country [1] 283952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287102 0
National Medical Ethics Committe of the Republic of Slovenia
Ethics committee address [1] 287102 0
Prof. Joze Trontelj, DrSc, MD, Chairman
University Institute of Clinical Neurophysiology,
Medical Center Ljubljana,
Zaloska c. 7,
SI-1525 Ljubljana
Ethics committee country [1] 287102 0
Slovenia
Date submitted for ethics approval [1] 287102 0
Approval date [1] 287102 0
13/12/2011
Ethics approval number [1] 287102 0

Summary
Brief summary
Purpuse: Intravenous fluid replacement is one of the main treatments of cardiovascular dysfunction in anaesthesia and intensive therapy. Only certain patients will respond to the administered fluids with and increase in cardiac output/stroke volume. Extra fluid could worsen the condition for the rest of the patients. Traditional predictive indices are not capable of predicting haemodynamic response to fluids. Recently, dynamic indices have emerged as consistent and reliable predictive factors for fluid responsiveness. Yet they have to date not been verified in the setting of increased intraabdominal pressure.

Hypothesis: Stroke volume variation and pulse pressure variation predict fluid responsiveness in patients with pneumoperitoneum.

Background: Pneumoperitoneum as a clinical model of intraabdominal hypertension has an effect on haemodynamic variables. Because of the reduced lung compliance it also affects dynamic indices of fluid responsiveness. It was demonstrated in animal studies that their predictive value for fluid responsiveness is maintained, but different cut-off values have been proposed.
The study design is explained above. We expect to find dynamic indices to have predictive value in the setting of pneumoperitoneum, possibly with different cut-off values.
The result is important for both clinical practice and further research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34060 0
Mr Marko Zlicar
Address 34060 0
University Medical Centre Ljubljana
Clinical Department of Anaesthesiology and Intensive Therapy
Zaloska 7
Ljubljana
Slovenia
Europe
Country 34060 0
Slovenia
Phone 34060 0
+38615223810
Fax 34060 0
Email 34060 0
[email protected]
Contact person for public queries
Name 17307 0
Mr Marko Zlicar
Address 17307 0
University Medical Center Ljubljana
Clinical Department for Anaesthesiology
Zaloska 7
1000 Ljubljana
Country 17307 0
Slovenia
Phone 17307 0
+38615223810
Fax 17307 0
Email 17307 0
[email protected]
Contact person for scientific queries
Name 8235 0
Mr Marko Zlicar
Address 8235 0
University Medical Center Ljubljana
Clinical Department for Anaesthesiology
Zaloska 7
1000 Ljubljana
Country 8235 0
Slovenia
Phone 8235 0
+38615223810
Fax 8235 0
Email 8235 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
SourceTitleYear of PublicationDOI
EmbasePredictive values of pulse pressure variation and stroke volume variation for fluid responsiveness in patients with pneumoperitoneum.2018https://dx.doi.org/10.1007/s10877-017-0081-4
N.B. These documents automatically identified may not have been verified by the study sponsor.