Clinical trial NCT02571465: Assessment of Fluid Responsiveness in Patients After Cardiac Surgery
Official title: Assessment of Fluid Responsiveness in Patients After Cardiac Surgery Comparison of Different Functional Hemodynamic Parameters and Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics
Patient Monitoring
Keywords: functional hemodynamic parameter
passive leg raising
stroke volume variation
pulse pressure variation
Lead sponsor: Triemli Hospital
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective off-pump CABG

Brief summary: 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

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Stroke volume increase > 15%
timeFrame: 20 min
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Triemli City Hospital
Study officials:
affiliation: Triemli City Hospital
name: Christoph K Hofer, MD DEAA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
citation: Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
citation: Ganter MT, Geisen M, Hartnack S, Dzemali O, Hofer CK. Prediction of fluid responsiveness in mechanically ventilated cardiac surgical patients: the performance of seven different functional hemodynamic parameters. BMC Anesthesiol. 2018 May 22;18(1):55. doi: 10.1186/s12871-018-0520-x.