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Assessment of Fluid Responsiveness in Patients After Cardiac Surgery

NCT ID: NCT02571465

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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).

Conditions

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Hemodynamics Patient Monitoring

Keywords

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functional hemodynamic parameter passive leg raising stroke volume variation pulse pressure variation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Passive leg raising test and fluid challenge

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triemli Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christoph K Hofer

MD DEAA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph K Hofer, MD DEAA

Role: PRINCIPAL_INVESTIGATOR

Triemli City Hospital

Locations

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Triemli City Hospital

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 19602972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16540963 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29788919 (View on PubMed)

Other Identifiers

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IFA10-3

Identifier Type: -

Identifier Source: org_study_id