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

Abstract

BackgroundThe 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.MethodsAfter 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.ResultsNinety 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.ConclusionsThe implementation of a specific hemodynamic goal-directed therapy did not reduce the overall incidence of BCIS in patients undergoing cemented hip arthroplasty.Trial registrationThis 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).

Goal-directed haemodynamic therapy (GDHT) in surgical patients: systematic review and meta-analysis of the impact of GDHT on post-operative pulmonary complications

“…The total sample size was <100 participants for 33 studies (Bahlmann et al, 2019;Bisgaard et al, 2013a;Bisgaard et al, 2013b;Cecconi et al, 2011;Colantonio et al, 2015;El Sharkawy et al, 2013;Funk et al, 2015;Han et al, 2016;Jammer et al, 2015;Joosten et al, 2019;Kaufmann et al, 2018;Kim et al, 2018;Kumar et al, 2016;Lobo et al, 2000;Mayer et al, 2010;Mikor et al, 2015;Mythen & Webb, 1995;Peng et al, 2014;Reisinger et al, 2017;Scheeren et al, 2013;Senagore et al, 2009;Shoemaker et al, 1988;Sinclair et al, 1997;Ueno et al, 1998;Van der Linden et al, 2010;Venn et al, 2002;Weinberg et al, 2017;Weinberg et al, 2019;Wu et al, 2017;Yin et al, 2018;Zakhaleva et al, 2013;Zeng et al, 2014;Zhang et al, 2013) (50%) and the majority (77%) were conducted in a single centre setting (Bartha et al, 2013;Bender et al, 1997;Benes et al, 2010;Bisgaard et al, 2013a;Bisgaard et al, 2013b;Boyd et al, 1993;Cecconi et al, 2011;…”

“…In nine studies (14%), there was incomplete outcome data (El Sharkawy et al, 2013;Jammer et al, 2015;Pestana et al, 2014;Salzwedel et al, 2013;Scheeren et al, 2013;Stens et al, 2017;Zakhaleva et al, 2013;Zeng et al, 2014;Zhang et al, 2013). Sixty-one studies (92%) were identified as at low risk of selective reporting bias (Ackland et al, 2015;Bahlmann et al, 2019;Bartha et al, 2013;Bender et al, 1997;Benes et al, 2010;Bisgaard et al, 2013a;Bisgaard et al, 2013b;Boyd et al, 1993;Brandstrup et al, 2012;Calvo-Vecino et al, 2018;Cecconi et al, 2011;Colantonio et al, 2015;Correa-Gallego et al, 2015;Davies et al, 2019;Donati et al, 2007;Funk et al, 2015;Gan et al, 2002;Gerent et al, 2018;Goepfert et al, 2013;Gomez-Izquierdo et al, 2017;Jammer et al, 2010;Joosten et al, 2019;Kaufmann et al, 2017;Kaufmann et al, 2018;Kim et al, 2018;Kumar et al, 2016;Luo et al, 2017;Mayer et al, 2010;McKendry et al, 2004;McKenny et al, 2013;Mikor ...…”

“…A summary table of study characteristics is presented in Table 2 , and an additional detailed table is available in the Supplementary material (Table A). The type of surgery performed was general/mixed group or abdominal (44 studies)(Ackland et al, 2015 ; Bahlmann et al, 2019 ; Benes et al, 2010 ; Boyd et al, 1993 ; Brandstrup et al, 2012 ; Calvo-Vecino et al, 2018 ; Colantonio et al, 2015 ; Correa-Gallego et al, 2015 ; Donati et al, 2007 ; El Sharkawy et al, 2013 ; Gan et al, 2002 ; Gerent et al, 2018 ; Gomez-Izquierdo et al, 2017 ; Jammer et al, 2010 ; Jammer et al, 2015 ; Joosten et al, 2019 ; Kim et al, 2018 ; Kumar et al, 2016 ; Lobo et al, 2000 ; Luo et al, 2017 ; Mayer et al, 2010 ; McKenny et al, 2013 ; Mikor et al, 2015 ; Pearse et al, 2005 ; Pearse et al, 2014 ; Pestana et al, 2014 ; Phan et al, 2014 ; Reisinger et al, 2017 ; Salzwedel et al, 2013 ; Sandham et al, 2003 ; Scheeren et al, 2013 ; Schmid et al, 2016 ; Senagore et al, 2009 ; Shoemaker et al, 1988 ; Stens et al, 2017 ; Ueno et al, 1998 ; Wakeling et al, 2005 ; Weinberg et al, 2017 ; Weinberg et al, 2019 ; Wilson et al, 1999 ; Wu et al, 2017 ; Yin et al, 2018 ; Zakhaleva et al, 2013 ; Zeng et al, 2014 ), orthopaedic (9 studies)(Bartha et al, 2013 ; Cecconi et al, 2011 ; Davies et al, 2019 ; Han et al, 2016 ; Kaufmann et al, 2018 ; Moppett et al, 2015 ; Peng et al, 2014 ; Sinclair et al,…”

“…Five studies were solely conducted on orthopaedic emergency patients(Bartha et al, 2013 ; Davies et al, 2019 ; Moppett et al, 2015 ; Sinclair et al, 1997 ; Venn et al, 2002 ), six additional studies included emergency surgical patients(Boyd et al, 1993 ; McKendry et al, 2004 ; Pearse et al, 2005 ; Pearse et al, 2014 ; Sandham et al, 2003 ; Shoemaker et al, 1988 ) and the rest were primarily conducted on elective surgical patients. The total sample size was <100 participants for 33 studies(Bahlmann et al, 2019 ; Bisgaard et al, 2013a ; Bisgaard et al, 2013b ; Cecconi et al, 2011 ; Colantonio et al, 2015 ; El Sharkawy et al, 2013 ; Funk et al, 2015 ; Han et al, 2016 ; Jammer et al, 2015 ; Joosten et al, 2019 ; Kaufmann et al, 2018 ; Kim et al, 2018 ; Kumar et al, 2016 ; Lobo et al, 2000 ; Mayer et al, 2010 ; Mikor et al, 2015 ; Mythen & Webb, 1995 ; Peng et al, 2014 ; Reisinger et al, 2017 ; Scheeren et al, 2013 ; Senagore et al, 2009 ; Shoemaker et al, 1988 ; Sinclair et al, 1997 ; Ueno et al, 1998 ; Van der Linden et al, 2010 ; Venn et al, 2002 ; Weinberg et al, 2017 ; Weinberg et al, 2019 ; Wu et al, 2017 ; Yin et al, 2018 ; Zakhaleva et al, 2013 ; Zeng et al, 2014 ; Zhang et al, 2013 ) (50%) and the majority (77%) were conducted in a single centre setting(Bartha et al, 2013 ; Bender et al, 1997 ; Benes et al, 2010 ; Bisgaard et al, 2013a ; Bisgaard et al, 2013b ; Boyd et al, 1993 ; Cecconi et al, 2011 ; Colantonio et a...…”

“…The monitoring device for the majority of the studies was minimally invasive (33 studies)(Ackland et al, 2015 ; Bahlmann et al, 2019 ; Bartha et al, 2013 ; Benes et al, 2010 ; Bisgaard et al, 2013a ; Bisgaard et al, 2013b ; Cecconi et al, 2011 ; Colantonio et al, 2015 ; Correa-Gallego et al, 2015 ; Funk et al, 2015 ; Gerent et al, 2018 ; Goepfert et al, 2013 ; Han et al, 2016 ; Jammer et al, 2015 ; Kim et al, 2018 ; Kumar et al, 2016 ; Luo et al, 2017 ; Mayer et al, 2010 ; Moppett et al, 2015 ; Osawa et al, 2016 ; Pearse et al, 2005 ; Pearse et al, 2014 ; Peng et al, 2014 ; Salzwedel et al, 2013 ; Scheeren et al, 2013 ; Schmid et al, 2016 ; Van der Linden et al, 2010 ; Weinberg et al, 2017 ; Weinberg et al, 2019 ; Wu et al, 2017 ; Xu et al, 2017 ; Zeng et al, 2014 ; Zhang et al, 2013 ), followed by oesophageal Doppler (17 studies)(Brandstrup et al, 2012 ; Calvo-Vecino et al, 2018 ; El Sharkawy et al, 2013 ; Gan et al, 2002 ; Gomez-Izquierdo et al, 2017 ; Kaufmann et al, 2017 ; Kaufmann et al, 2018 ; McKendry et al, 2004 ; McKenny et al, 2013 ; Mythen & Webb, 1995 ; Phan et al, 2014 ; Reisinger et al, 2017 ; Senagore et al, 2009 ; Sinclair et al, 1997 ; Venn et al, 2002 ; Wakeling et al, 2005 ; Zakhaleva et al, 2013 ), pulmonary artery catheter (8 studies)(Bender et al, 1997 ; Boyd et al, 1993 ; Lobo et al, 2000 ; Sandh...…”