Assessment of Fluid Responsiveness in Patients After Cardiac Surgery

To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.

Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the transition from controlled to spontaneous breathing in cardiac surgery patients

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Key information

Conditions

Hemodynamics Patient Monitoring

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Triemli City Hospital

Zurich, Canton of Zurich, 8063, Switzerland

About this study

In patients after elective off-pump CABG are enrolled hemodynamic measurements are performed in the postoperative period upon arrival in the ICU using a PiCCO2 system (Pulsion Medical Systems, Munich, Germany).

Controlled fluid challenges (500 ml) are done at 3 time-points:

A) during controlled mechanical ventilation B) during pressure support ventilation with spontaneous breathing and C) after extubation.

Stroke volume (SV), SVV and PPV as well as standard hemodynamic parameters (MAP = mean arterial pressure, HR = heart rate) are assessed.

A PLR is performed before fluid administration at all 3 time points. A positive response is defined as an increase in SV>15 %.

Prediction of fluid responsiveness will be tested by AUC (area under the receiver operating characteristic - ROC - curve).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

preserved left ventricular function
regular heart rhythm

Exclusion criteria

emergency procedures
intra- and extra-cardial shunts
aortic and tricuspid valve insufficiencies
peripheral arterial occlusive disease

Treatment and study plan

Passive leg raising test and fluid challenge

Other

Primary outcomes

Stroke volume increase > 15%

Time frame: 20 min

Stroke volume increase defines fluid responsiveness

Sponsors and collaborators

Lead sponsor

Triemli Hospital

Other

Registry information

Official study title

Assessment of Fluid Responsiveness in Patients After Cardiac Surgery Comparison of Different Functional Hemodynamic Parameters and Tests

Acronym: POP

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Oct 8, 2015
Registry last updated: Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed