ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Cardiovascular

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]

Not applicable

Comparator / control treatment

No control treatment.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At 5 minutes after starting a fluid challenge.

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Slovenia

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

University Medical Centre Ljubljana

Address [1]

Zaloska 7
1000 Ljubljana

Country [1]

Slovenia

Primary sponsor type

Hospital

Name

University Medical Centre Ljubljana

Address

Zaloska 7
1000 Ljubljana

Country

Slovenia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Medical Ethics Committe of the Republic of Slovenia

Ethics committee address [1]

Prof. Joze Trontelj, DrSc, MD, Chairman
University Institute of Clinical Neurophysiology,
Medical Center Ljubljana, 
Zaloska c. 7,
SI-1525 Ljubljana

Ethics committee country [1]

Slovenia

Date submitted for ethics approval [1]

Approval date [1]

13/12/2011

Ethics approval number [1]

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

Mr Marko Zlicar

Address

University Medical Centre Ljubljana
Clinical Department of Anaesthesiology and Intensive Therapy
Zaloska 7
Ljubljana
Slovenia
Europe

Country

Slovenia

Phone

+38615223810

Fax

[email protected]

Contact person for public queries

Name

Marko Zlicar

Address

University Medical Center Ljubljana
Clinical Department for Anaesthesiology
Zaloska 7
1000 Ljubljana

Country

Slovenia

Phone

+38615223810

Fax

[email protected]

Contact person for scientific queries

Name

Marko Zlicar

Address

University Medical Center Ljubljana
Clinical Department for Anaesthesiology
Zaloska 7
1000 Ljubljana

Country

Slovenia

Phone

+38615223810

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Predictive values of pulse pressure variation and stroke volume variation for fluid responsiveness in patients with pneumoperitoneum.	2018	https://dx.doi.org/10.1007/s10877-017-0081-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically