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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02571465
Other study ID # IFA10-3
Secondary ID
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


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
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