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Randomized Controlled Trial
. 2018 Jun 6;18(1):63.
doi: 10.1186/s12871-018-0526-4.

Evaluation of hemodynamic goal-directed therapy to reduce the incidence of bone cement implantation syndrome in patients undergoing cemented hip arthroplasty - a randomized parallel-arm trial

Affiliations
Randomized Controlled Trial

Evaluation of hemodynamic goal-directed therapy to reduce the incidence of bone cement implantation syndrome in patients undergoing cemented hip arthroplasty - a randomized parallel-arm trial

Kai B Kaufmann et al. BMC Anesthesiol. .

Abstract

Background: The bone cement implantation syndrome (BCIS) is a frequent and potentially disastrous intraoperative complication in patients undergoing cemented hip arthroplasty. Several risk factors have been identified, however randomized controlled trials to reduce the incidence of BCIS are still pending. We hypothesized that goal-directed hemodynamic therapy guided by esophageal Doppler monitoring (EDM) may reduce the incidence of BCIS in a randomized, controlled parallel-arm trial.

Methods: After approval of the local ethics committee, 90 patients scheduled for cemented hip arthroplasty at the Medical Center - University of Freiburg were randomly assigned to either standard hemodynamic management or goal-directed therapy (GDT) guided by an esophageal Doppler monitoring-based algorithm. The primary endpoint was the incidence of overall BCIS including grade 1-3 after cementation of the femoral stem. Secondary endpoints included cardiac function, length of hospital stay and postoperative complications.

Results: Ninety patients were finally analyzed. With regards to the primary endpoint, the overall incidence of BCIS showed no difference between the GDT and control group. Compared to the control group, patients of the GDT group showed a higher cardiac index before and after bone cement implantation (2.7 vs. 2.2 [l●min- 1●m- 2]; 2.8 vs. 2.4 [l●min- 1●m- 2]; P = 0.003, P = 0.042), whereas intraoperative amount of fluids and mean arterial pressure did not differ.

Conclusions: The implementation of a specific hemodynamic goal-directed therapy did not reduce the overall incidence of BCIS in patients undergoing cemented hip arthroplasty.

Trial registration: This randomized clinical two-arm parallel study was approved by the local Ethics Committee, Freiburg, Germany [EK 160/15, PI: U. Goebel] and registered in the German Clinical Trials Register ( DRKS No. 00008778 , 16th of June, 2015).

Keywords: Hemodynamics; Hip arthroplasty; Postoperative complications.

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Conflict of interest statement

Ethics approval and consent to participate

This randomized clinical two-arm parallel study was approved by the local Ethics Committee, Freiburg, Germany [EK 160/15, PI: U. Goebel] and registered in the German Clinical Trials Register (DRKS No. 00008778, 16th of June, 2015). Written informed consent to participate in this study was obtained from each patient prior to study enrollment.

Consent for publication

Consent for publication was obtained from each patient enrolled in this study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT Statement
Fig. 2
Fig. 2
(a) Goal-directed hemodynamic therapy (GDT) (b) Standard hemodynamic algorithm. (a) Goal-directed hemodynamic algorithm to guide intraoperative volume, vasopressor and inotropic therapy in the Goal-directed therapy group adopted from ERAS [13]. (b) Hemodynamic algorithm to guide intraoperative volume, vasopressor and inotropic therapy in the control group according to the standard operating procedure of the department of orthopedic anesthesia

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