Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)

Vecino, J.M. Calvo; Ripollés‐Melchor, Javier; Mythen, Monty; Francés, R. Casans; Balık, Ahmet A.; Artacho, Julián; Martínez‐Hurtado, Eugenio; Romero, Ana Serrano; Fernández-Pérez, Cristina; Lis, Steffen; Errazquin, Ana Tirado; Lapetra, Cristina Gil; Abad‐Motos, Ane; Garrido, Elena; Viñas, Cristina Medrano; Villaba, Raúl; Cobeta, Pilar; Ureta, Eva; Montiel, M Rigabert; Mané, Nuria; Castro, Nilda Martínez; Horno, Gema Aleson; Salas, Rebeca Alonso; García, Carmen Bona; Ferrer, Marta Lucía Ferrer; Abad, Marta Franco; Lecina, Ana Cristina García; Antón, Julia Guillén; Gascón, Guillermo Hojas; Deza, Javier Peligro; Pascual, Leticia Pérez; Garcés, Tomàs; Alcácer, Ana Teresa Roberto; Badura, Marek; Galera, Eduardo Terrer; Casares, Antonio Fernández; Fernández, Maria Carmen Martínez; Espinosa, Á.; Abad‐Gurumeta, Alfredo; Feldheiser, Aarne; Timoneda, F. López; Zuleta-Alarcon, Alix; Bergese, Sergio D.

doi:10.1016/j.bja.2017.12.018

Cited by 172 publications

(120 citation statements)

References 65 publications

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“…It was traditionally believed that these patients are able to adapt to perioperative stress therefore, they do not need any hemodynamic monitoring and strategy. A recent RCT (10), which was included in the present meta-analysis, supported this hypothesis. It is noteworthy that the most robust result of the present meta-analysis was observed in the subgroup analysis enrolling trials that adopted indices of preload as a hemodynamic target.…”

Section: Discussionsupporting

confidence: 61%

“…Goal-directed therapy (GDT) is a method which monitors the cardiac output and other basic hemodynamic parameters to optimize doses and timing of fluids, inotropes, and vasopressors. Several meta-analyses (8,9) have suggested that GDT can reduce postoperative complications in high-risk patients, and a recent trial has also pointed to the significant effect of GDT on low or moderate-risk patients (10). Although hemodynamic monitoring is recommended by national guidelines (11,12), a worldwide variability still exists in the adaptation of this strategy.…”

Section: Introductionmentioning

confidence: 99%

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Is perioperative goal-directed therapy able to reduce surgical complications in different surgical settings? A meta-analytic study

Giglio

Biancofiore²,

Puntillo

et al. 2019

jsurgery

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Introduction: Goal directed therapy (GDT) is a method aiming at optimizing doses and timing of fluids, inotropes and vasopressors, through monitoring of cardiac output and other basic hemodynamic parameters. Several meta-analyses confirm that GDT can reduce postoperative complications in high risk patients, and a recent trial suggests its significant effect also in low-moderate risk patients. The aim of the present meta-analysis is to investigate the effect of GDT on postoperative complications, in both high and low risk patients. Moreover, we stratified the effect of GDT in different kind of surgical procedures. Methods:Randomized controlled trials (RCTs) on perioperative GDT in adult surgical patients were included. The primary outcome measure was complications, defined as number of patients with a least one postoperative complication. A subgroupanalysis was also performed including RCTs with a mortality rate in control group <10%, and considering the kind of surgery: major abdominal (including also major vascular), only vascular, only orthopedic surgery and so on. Meta-analytic techniques (analysis software RevMan, version 5.3.5, Cochrane Collaboration, Oxford, England, UK) were used to combine studies using odds ratios (ORs) and 95% confidence intervals (CIs). Results:In 47 RCTs, 2329 patients developed at least one complication: 1030 out of 2781 (37%) were randomized to perioperative GDT, and 1299 out of 2772 (47%) were randomized to control. Pooled OR was 0.58 and 95% CI was 0.47-0.70. The sensitivity analysis confirmed main result. The subgroup analysis including only studies in which the mortality rate in the control group was higher than 10% showed significant results (OR 0.51, 95% CI 0.35-0.74, p=0.004, 10 RCTs), as well as a statistical significant effect was observed in those RCTs with a mortality rate in control group <10% (OR 0.59, 95% CI 0.47-0.74, p<0.0001, 37 RCTs). The subgroup analysis enrolling major abdominal patients showed a significant result (OR 0.69, 95% CI 0.57-0.83,p <0.0001, 29 RCTs, 3881 patients) as well as a significant effect was observed in those RCTs enrolling exclusively orthopedic (OR 0.48, 95% CI 0.30-0.79,p=0.004, 6 RCTs, 501 patients) and neurosurgical procedures (OR 0.40, 95% CI 0.21-0.78, p=0.008, 2 RCTs, 208 patients). Conclusions:The present meta-analysis suggests that GDT can reduce postoperative complication rate in high risk as well as in low risk patients. Moreover, the beneficial effect of GDT on postoperative morbidity is significant on major abdominal, orthopedic and neurosurgical procedures. However, heterogeneity was found in some subgroups, reducing the strength of the results. Several well-designed RCTs are needed to further explore the effect of GDT in low risk patient and in different kind of surgeries.

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Section: Discussionsupporting

confidence: 61%

Section: Introductionmentioning

confidence: 99%

Is perioperative goal-directed therapy able to reduce surgical complications in different surgical settings? A meta-analytic study

Giglio

Biancofiore²,

Puntillo

et al. 2019

jsurgery

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“…38 A recent trial demonstrated that perioperative hypotensive episodes, defined as systolic blood pressure less than 90 mmHg for more than 10 minutes, are major contributors to cardiovascular events, even in patients without coronary artery disease. 39 It seems likely, that intraoperative goal-directed 18 We tightly controlled intraoperative blood pressure, which resulted in a time-weighted average mean arterial pressure of near 80 mmHg in both groups. However, during the first two postoperative days 5 (19%) patients in the colloid and 7 (24%) patients in the crystalloid group developed MINS.…”

Section: Discussionmentioning

confidence: 99%

“…1 15 Goal-directed perioperative fluid strategies are used to improve haemodynamic stability and to optimize cardiac performance 16 with the aim to reduce postoperative morbidity and mortality. [17][18][19] Due to favourable plasma expanding effects colloid solutions are considered to be superior for intraoperative volume therapy compared to crystalloid solutions. 20 21 Goal-directed colloid administration not only reduces the required amount of fluid for maintaining haemodynamic stability during surgery but also allows to distinguish whether patients need fluid or vasopressors at any given point in time.…”

Section: Introductionmentioning

confidence: 99%

Effect of Intraoperative Goal-directed Balanced Crystalloid versus Colloid Administration on Postoperative Cardiac Outcome

Reiterer

Kabon²,

Taschner

et al. 2020

Preprint

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Background : N-terminal pro brain natriuretic peptide (NT-proBNP) and troponin T are released during myocardial wall stress and/or ischemia and are strong predictors for postoperative cardiovascular complications. However, the effect of goal-directed crystalloid versus colloid administration on NT-proBNP and troponin T, especially in relatively healthy patients undergoing moderate- to high risk abdominal surgery, still remains unclear. Thus, we evaluated in this subanalysis the effect of a goal-directed crystalloid versus a goal-directed colloid fluid regimen on postoperative cardiac outcome. Methods: 30 patients were randomly assigned to receive additional fluid boluses of 6% hydroxyethyl starch 130/0.4 and 30 patients to receive lactated Ringer´s solution. Intraoperative fluid management was guided by oesophageal Doppler according to a previously published algorithm. The primary outcome were differences of maximum NT-proBNP (maxNT-proBNP) and maximum troponin T (maxTnT) concentrations during the first two postoperative days between both study groups. We defined maxNT-proBNP and maxTnT as maximum values measured 2 hours after surgery and on the first and second postoperative day. Results: In total 56 patients were analysed. There was no significant difference in postoperative maximum NT-proBNP between the colloid group (258.7 ng/L (IQR 199.4 to 782.1)) and the crystalloid group (440.3 ng/L (IQR 177.9 to 691.2)) during the first 2 postoperative days ( P = 0.29). 5 patients in the colloid group and 7 patients in the crystalloid group developed MINS ( P = 0.75). Conclusions: Postoperative cardiac outcome as defined by cardiac biomarkers was not significantly affected by goal-directed colloid administration; however, there was a tendency of lower maximum NT-proBNP concentrations in patients receiving colloids. Trial registration: ClinicalTrials.gov (NCT01195883)

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“…2,3 Multicentre randomized controlled trials (RCTs) and meta-analyses suggest that IFM is beneficial in decreasing postoperative morbidity, shortening hospital length of stay and saving costs. [6][7][8][9][10][11] Most IFM studies have been conducted in patients undergoing major gastro-intestinal surgery . [10][11][12] A limited number of studies have been done among patients undergoing orthopaedic surgery and have yielded conflicting results.…”

Section: Introductionmentioning

confidence: 99%

Outcome impact of individualized fluid management during spine surgery A before-after prospective comparison study

Che

Zhang

et al. 2020

Preprint

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Background Individualized fluid management (IFM) has been shown to be useful to improve the postoperative outcome of patients undergoing major abdominal surgery. A limited number of clinical studies have been done in orthopaedic patients and have yielded conflicting results. We designed the present study to investigate the clinical impact of IFM in patients undergoing major spine surgery. Methods This is a before-after study done in 300 patients undergoing posterior spine arthrodesis. Postoperative outcomes were compared between control group implementing standard fluid management (n = 150) and IFM group (n = 150) guided by fluid protocol based on continuous stroke volume monitoring and optimization. The primary outcome measure was the proportion of patients who developed one or more complications within 30 days following surgery. Results During surgery, patients received on average the same volume of crystalloids (7.4 vs 7.2 ml/kg/h) and colloids (1.6 vs 1.6 ml/kg/h) before and after the implementation of IFM. During 30 days following surgery, the proportion of patients who developed one or more complications was lower in the IFM group (32 vs 48%, p<0.01). This difference was mainly explained by a significant decrease in post-operative nausea and vomiting (from 38 to 19%, p<0.01), urinary tract infections (from 9 to 1%, p<0.01) and surgical site infections (from 5 to 1%, p<0.05). Median hospital length of stay was not affected by the implementation of IFM. Conclusions In patients undergoing major spine surgery, the implementation of IFM was associated with a significant decrease in postoperative morbidity.

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Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)

Abstract: ISRCTN93543537.

Cited by 172 publications

References 65 publications

Is perioperative goal-directed therapy able to reduce surgical complications in different surgical settings? A meta-analytic study

Is perioperative goal-directed therapy able to reduce surgical complications in different surgical settings? A meta-analytic study

Effect of Intraoperative Goal-directed Balanced Crystalloid versus Colloid Administration on Postoperative Cardiac Outcome

Outcome impact of individualized fluid management during spine surgery A before-after prospective comparison study

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