Assessment of Fluid Responsiveness in Patients After Cardiac Surgery (POP)

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

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

Study Overview

• Status: Completed
• Conditions: Hemodynamics; Patient Monitoring
• Intervention / Treatment: Other: Passive leg raising test and fluid challenge

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).

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8063
    • Triemli City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective off-pump CABG

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke volume increase > 15%	Stroke volume increase defines fluid responsiveness	20 min

Collaborators and Investigators

• Sponsor: Triemli Hospital
• Investigators: Principal Investigator: Christoph K Hofer, MD DEAA, Triemli City Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (ESTIMATE): October 8, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: pulse pressure variation; stroke volume variation; passive leg raising; functional hemodynamic parameter
• Other Study ID Numbers: IFA10-3