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A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery.

ABSTRACT: Intraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. We tested this hypothesis in a multi-center study.The patients were included in two periods: a first control period (control group; n?=?147) in which intraoperative fluids were given according to clinical judgment. After a training period, intraoperative fluid management was titrated to maintain PPV?

SUBMITTER: Malbouisson LMS

PROVIDER: S-EPMC5450107 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery.

Malbouisson Luiz Marcelo Sá LMS Silva João Manoel JM Carmona Maria José Carvalho MJC Lopes Marcel Rezende MR Assunção Murilo Santucci MS Valiatti Jorge Luís Dos Santos JLDS Simões Claudia Marques CM Auler José Otavio Costa JOC

BMC anesthesiology 20170530 1

<h4>Background</h4>Intraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. We tested this hypothesis in a multi-center study.<h4>Methods</h4>The patients were included in two periods: a first control period (control group; n = 147) in which intraoperative fluids were given according to clinical judgment. After a training period, intraoperative fluid management was titrated to maintain PPV < 10% in 109 surgical ...[more]

PMID: 28558654

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Project description:Study designProspective, randomized, controlled study.PurposeTo determine whether the use of goal-directed fluid therapy (GDT) guided by pulse-pressure variation (PPV) and fluid management protocol can reduce intraoperative hypotension, blood transfusion requirements, and postoperative complications in adults undergoing complex spine surgery.Overview of literatureComplex spine surgeries involve a significant risk of blood loss and intraoperative hypotension. Previous studies showed that GDT reduces intraoperative hypotension and postoperative complications in these surgery types; however, limited information exists about GDT guided by PPV.MethodsSixty adults (18-70 years) patients undergoing complex spine surgeries at Siriraj Hospital, Mahidol University, Thailand were enrolled. Patients were allocated to two groups (30 patients in each) using computer-generated randomization. Intraoperative fluid and vasopressor were administrated via either GDT or standard care. The GDT algorithm used PPV and fluid protocol as the primary tool to guide hemodynamic management. The incidences and episodes of perioperative hypotension were measured as the outcomes.ResultsFifty-seven patients were analyzed (three patients in the GDT group were excluded). The baseline characteristics and surgical procedures of the two groups did not differ significantly. The prevalence of intraoperative hypotension was 80.0% for the control group and 66.7% for the GDT group (p=0.25). Two episodes (1-3) of intraoperative hypotension occurred in the control group, and one episode (0-3) occurred in the GDT group; the difference was not significantly different (p=0.57). The intraoperative blood transfusion requirements and postoperative complications were similar in both the groups. In the subgroup analysis, patients with intraoperative hypotension exhibited a higher incidence of postoperative bowel dysfunction.ConclusionsPPV-guided GDT and fluid protocol, as compared with standard practice, did not show significant advantages with respect to intraoperative hypotension, blood transfusion, or postoperative complications in patients undergoing complex spine surgery in the prone position.

Project description:BackgroundGoal-directed fluid therapy (GDFT) based on dynamic indicators of fluid responsiveness has been shown to decrease postoperative complications and hospital length of stay (LOS) in patients undergoing major abdominal surgery. The usefulness of this approach still needs to be clarified in low-to-moderate risk abdominal surgery. Both pulse-pressure variation (PPV) and pleth variability index (PVI) can be used to guide GDFT strategies. The objective of this prospective randomized controlled trial was to determine if the use of PVI guided GDFT, when compared to PPV guided GDFT, would lead to similar hospital LOS in patients undergoing low-to-moderate risk surgery. Secondary outcomes included amount of fluid administered and incidence of postoperative complications.MethodsPatients were randomized into either PVI or PPV guided GDFT groups. Both received a baseline 2 ml kg- 1 h- 1 Lactated Ringer infusion. Additional fluid boluses consisted of 250 mL of colloid that was infused over a 10 min period if PVI was > 15% or PPV was > 13% for at least five minutes. The primary outcome was to determine if hospital LOS, which was defined as the number of days from surgery up to the day the surgeon authorized hospital discharge, was equivalent between the two groups.ResultsA total of 76 patients were included and they were randomized into two groups of 38 patients. Baseline characteristics were similar in both groups. Both PVI and PPV guided GDFT strategies were equivalent for the primary outcome of LOS (median [interquartile range]) (days) 2.5 [2.0-3.3] vs. 3.0 [2.0-5.0], p = 0.230, respectively. Fluids infused, postoperative complications, and all other outcomes were not different between groups.ConclusionIn patients undergoing low-to-moderate risk abdominal surgery, PVI seems to guide GDFT similarly to PPV in regards to hospital LOS, amount of fluid, and incidence of postoperative complications. However, in low-risk patients undergoing these surgical procedures optimizing stroke volume may have limited impact on outcome.Trial registrationClinicalTrials.gov Identifier: NCT02908256 , September 2016, retrospectively registered.

Project description:BackgroundSeveral randomized controlled trials suggest that goal-directed fluid therapy (GDFT) may result in improved postoperative outcomes. The aim of this study was to assess the clinical and financial impact of the real-life implementation of intraoperative GDFT in patients undergoing elective gastrointestinal surgery in a Chinese tertiary medical center.MethodsThis Quality Improvement Program (QIP) study comprised three phases of 5, 1, and 5 months, respectively. During the first phase, we retrospectively collected perioperative data from patients who received standard intraoperative fluid management from January to May 2016. Then a 1-month training period allowed the clinical staff to become familiar with the GDFT protocol. After the training phase, GDFT was used from July to November 2016. In the GDFT group, stroke volume (SV) was continuously monitored and optimized towards the plateau of the Frank-Starling curve. The primary outcome measure was postoperative morbidity (the proportion of patients with one or more complications within 30 days after surgery). Secondary outcomes were total hospital cost, postoperative length of hospital stay, and 30-day mortality.ResultsData from 200 patients before (control group) and 201 patients after the implementation of GDFT (GDFT group) were collected and compared. There was no significant difference in demographics and surgical procedures between the two groups. Postoperative morbidity was significantly lower in the GDFT group than in the control group (30.8% vs. 44.0%, p = 0.006). No significant differences were observed for mean total hospital cost (76,793 RMB vs. 74,444 RMB; p = 0.430), median postoperative length of hospital stay (10 days vs. 10 days; p = 0.104), and 30-day mortality (1% vs. 0.5%; p = 0.565).ConclusionIn patients undergoing gastrointestinal surgery, the implementation of a GDFT protocol was associated with a reduction in postoperative morbidity without increasing costs.Trial registrationclinicaltrials.gov, NCT02507557. Registered 13 July 2015.

Project description:The optimal perioperative fluid resuscitation strategy for liver resections remains undefined. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.In a prospective randomized trial, patients undergoing liver resection were randomized to GDT using stroke volume variation as an end point or to standard perioperative resuscitation. Primary outcomes measure was 30-day morbidity.Between 2012 and 2014, one hundred and thirty-five patients were randomized (GDT: n = 69; standard perioperative resuscitation: n = 66). Median age was 57 years and 56% were male. Metastatic disease comprised 81% of patients. Overall (35% GDT vs 36% standard perioperative resuscitation; p = 0.86) and grade 3 morbidity (28% GDT vs 18% standard perioperative resuscitation; p = 0.22) were equivalent. Patients in the GDT arm received less intraoperative fluid (mean 2.0 L GDT vs 2.9 L standard perioperative resuscitation; p < 0.001). Perioperative transfusions were required in 4% (6% GDT vs 2% standard perioperative resuscitation; p = 0.37) and boluses in the postanesthesia care unit were administered to 24% (29% GDT vs 20% standard perioperative resuscitation; p = 0.23). Mortality rate was 1% (2 of 135 patients; both in GDT). On multivariable analysis, male sex, age, combined procedures, higher intraoperative fluid volume, and fluid boluses in the postanesthesia care unit were associated with higher 30-day morbidity.Stroke volume variation-guided GDT is safe in patients undergoing liver resection and led to less intraoperative fluid. Although the incidence of postoperative complications was similar in both arms, lower intraoperative resuscitation volume was independently associated with decreased postoperative morbidity in the entire cohort. Future studies should target extensive resections and identify patients receiving large resuscitation volumes, as this population is more likely to benefit from this technique.

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A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery.

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A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery.

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