A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185)

Abstract

Background Hip fracture is a procedure with high mortality and complication rates, and there exists a group especially at risk of these outcomes identified by their Nottingham Hip Fracture Score (NHFS). Meta-analysis suggests a possible benefit to this patient group from intravascular volume optimisation. We investigated whether intraoperative fluid and blood pressure optimisation improved complications in this group. Methods Patients with a NHFS ≥ 5 were enrolled into this multicentre observer-blinded randomised control trial. Patients were allocated to either standard care or a combination of fluid optimisation and blood pressure control using a non-invasive system. The primary outcome was the number of patients with one or more complications in each group. Secondary outcomes included hospital length of stay (LOS), incidence of hypotension and fluid and vasopressor usage. Results Forty-six percent of patients in the intervention group suffered one or more complications compared to the 51% in the control group (OR 0.82 (95% CI 0.49–1.36)). Per-protocol analysis improved the OR to 0.73 (95% CI 0.43–1.24). Median LOS was the same between both groups; however, the mean LOS on a per-protocol analysis was longer in the control group compared to the intervention group (23.2 (18.0) days vs. 18.5 (16.5), p = 0.047). Conclusions Haemodynamic optimisation including blood pressure management in high-risk patients undergoing repair of a hip fracture did not result in a statistically significant reduction in complications; however, a potential reduction in length of stay was seen. Trial registration A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185 ).

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

“…Among those which used inotropes, more than 50% used dobutamine (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;Donati et al, 2007;Gerent et al, 2018;Kim et al, 2018;Kumar et al, 2016;Lobo et al, 2000;Mayer et al, 2010;Osawa et al, 2016;Pestana et al, 2014;Salzwedel et al, 2013;Schmid et al, 2016;Shoemaker et al, 1988;Stens et al, 2017;Ueno et al, 1998;Van der Linden et al, 2010;Wu et al, 2017;Xu et al, 2017;Yin et al, 2018;Zhang et al, 2013). The fluid bolus in the GDHT algorithm consisted of a colloid solution in nearly two-thirds of the studies (Cecconi et al, 2011;Chappell et al, 2008;Chong et al, 2018;Correa-Gallego et al, 2015;Davies et al, 2019;Donati et al, 2007;Eappen et al, 2013;El Sharkawy et al, 2013;Evans et al, 2009;Funk et al, 2015;Gerent et al, 2018;Goepfert et al, 2013;Gomez-Izquierdo et al, 2017;Grocott et al, 2012;…”

“…(Higgins & Green, 2011) Each study was assessed according to seven domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other biases. Random sequence generation was identified as at low risk of bias in 45 studies (68%) (Cecconi et al, 2011;Chappell et al, 2008;Chong et al, 2018;Correa-Gallego et al, 2015;Davies et al, 2019;Donati et al, 2007;Eappen et al, 2013;Edwards et al, 2019;Evans et al, 2009;Grocott et al, 2012;Grocott et al, 2005;Guyatt et al, 2008;Hamilton et al, 2011;Higgins & Green, 2011; http:// www.isrctn.com/ISRCTN14729158, n.d.; Jammer et al, 2015;Jammer et al, 2010;Jhanji et al, 2010;Joosten et al, 2019;Kim et al, 2018;Lobo et al, 2000;McKendry et al, 2004;Mikor et al, 2015;Moppett et al, 2015;Mythen & Webb, 1995;Noblett et al, 2006;Osawa et al, 2016;Pearse et al, 2005;Pearse et al, 2014;Peng et al, 2014;Phan et al, 2014;Polonen et al, 2000;Reisinger et al, 2017;Sandham et al, 2003;Schmid et al, 2016;Senagore et al, 2009;Sinclair et al, 1997;Sriniv...…”

“…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 ...…”

“…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, 1997 ; Venn et al, 2002 ), cardiothoracic (7 studies) (Goepfert et al, 2013 ...…”

Hydroxyethyl starch for perioperative goal-directed fluid therapy in 2020: a narrative review

“…Adequate GDFT for patients undergoing major surgery requires that stroke volume or cardiac output are monitored to assess fluid responsiveness and that an algorithm is designed that will be applied by all members of the anesthesia team. Admittedly, some studies have not demonstrated a beneficial effect of GDFT on patient outcome [21][22][23][24][25]. However, these studies were mainly underpowered and/ or conducted in relatively healthy patients with minimal fluid shift and blood loss [23,24,[26][27][28].…”