Assessment of Fluid Responsiveness in Patients After Cardiac Surgery

Hemodynamics Clinical Trial

— POP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571465
• Other study ID #: IFA10-3
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: November 14, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Triemli Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemodynamics
• Patient Monitoring

Intervention

Other:
• Passive leg raising test and fluid challenge

Locations

Country	Name	City	State
Switzerland	Triemli City Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Triemli Hospital

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke volume increase > 15%	Stroke volume increase defines fluid responsiveness	20 min	No