Dataset Information

Goal directed fluid therapy for major liver resection: A multicentre randomized controlled trial.

ABSTRACT:

Background

The effect a restrictive goal directed therapy (GDT) fluid protocol combined with an enhanced recovery after surgery (ERAS) programme on hospital stay for patients undergoing major liver resection is unknown.

Methods

We conducted a multicentre randomized controlled pilot trial evaluating whether a patient-specific, surgery-specific intraoperative restrictive fluid optimization algorithm would improve duration of hospital stay and reduce perioperative fluid related complications.

Results

Forty-eight participants were enrolled. The median (IQR) length of hospital stay was 7.0 days (7.0:8.0) days in the restrictive fluid optimization algorithm group (Restrict group) vs. 8.0 days (6.0:10.0) in the conventional care group (Conventional group) (Incidence rate ratio 0.85; 95% Confidence Interval 0.71:1.1; p = 0.17). No statistically significant difference in expected number of complications per patient between groups was identified (IRR 0.85; 95%CI: 0.45-1.60; p = 0.60). Patients in the Restrict group had lower intraoperative fluid balances: 808 mL (571:1565) vs. 1345 mL (900:1983) (p = 0.04) and received a lower volume of fluid per kg/hour intraoperatively: 4.3 mL/kg/hr (2.6:5.8) vs. 6.0 mL/kg/hr (4.2:7.6); p = 0.03. No significant differences in the proportion of patients who received vasoactive drugs intraoperatively (p = 0.56) was observed.

Conclusion

In high-volume hepatobiliary surgical units, the addition of a fluid restrictive intraoperative cardiac output-guided algorithm, combined with a standard ERAS protocol did not significantly reduce length of hospital stay or fluid related complications. Our findings are hypothesis-generating and a larger confirmatory study may be justified.

SUBMITTER: Weinberg L

PROVIDER: S-EPMC6642079 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Goal directed fluid therapy for major liver resection: A multicentre randomized controlled trial.

Weinberg Laurence L Ianno Damian D Churilov Leonid L Mcguigan Steven S Mackley Lois L Banting Jonathan J Shen Shi Hong SH Riedel Bernhard B Nikfarjam Mehrdad M Christophi Chris C

Annals of medicine and surgery (2012) 20190710

<h4>Background</h4>The effect a restrictive goal directed therapy (GDT) fluid protocol combined with an enhanced recovery after surgery (ERAS) programme on hospital stay for patients undergoing major liver resection is unknown.<h4>Methods</h4>We conducted a multicentre randomized controlled pilot trial evaluating whether a patient-specific, surgery-specific intraoperative restrictive fluid optimization algorithm would improve duration of hospital stay and reduce perioperative fluid related compl ...[more]

PMID: 31360460

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Project description:BackgroundThe 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.Study designIn 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.ResultsBetween 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.ConclusionsStroke 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.

Project description:BackgroundFluid management during major gynecologic oncology surgeries faces great challenges due to the distinctive characteristics of patients with gynecologic malignancies as well as features of the surgical procedure. Intraoperative goal-directed fluid therapy (GDFT) has been proven to be effective in reducing postoperative complications among major colorectal surgeries; however, the efficacy of GDFT has not been fully studied in gynecologic malignancy surgeries. This study aimed to discuss the influence of GDFT practice in patients undergoing major gynecologic oncology surgery.MethodsThis study was a controlled before-and-after study. From June 2015 to June 2018 in Peking Union Medical College Hospital, a total of 300 patients scheduled for elective laparotomy of gynecological malignancies were enrolled and chronologically allocated into two groups, with the earlier 150 patients in the control group and the latter 150 patients in the GDFT group. The GDFT protocol was applied by Vigileo/FloTrac monitoring of stroke volume and fluid responsiveness to guide intraoperative fluid infusion and the use of vasoactive agents. The primary outcome was postoperative complications within 30 days after surgery. The secondary outcome included length of stay and time of functional recovery.ResultsA total of 249 patients undergoing major gynecologic oncology surgery were analyzed in the study, with 129 in the control group and 120 patients in the GDFT group. Patients in the GDFT group had higher ASA classifications and more baseline comorbidities. GDFT patients received significantly less fluid infusion than the control group (15.8 vs. 17.9 ml/kg/h), while fluid loss was similar (6.9 vs. 7.1 ml/kg/h). GDFT was associated with decreased risk of postoperative complications (OR = 0.572, 95% CI 0.343 to 0.953, P = 0.032), especially surgical site infections (OR = 0.127, 95% CI 0.003 to 0.971, P = 0.037). The postoperative bowel function recovery and length of hospital stay were not significantly different between the two groups.ConclusionGoal-directed intraoperative fluid therapy is associated with fewer postoperative complications in patients undergoing major gynecologic oncology surgery.

Project description:BackgroundPostoperative ileus is a common complication of intraabdominal surgeries, including radical cystectomy with reported rates as high as 32%. Perioperative fluid administration has been associated with improvement in postoperative ileus rates, but it is difficult to generalize because earlier studies lacked standardized definitions of postoperative ileus and other relevant outcomes. The hypothesis was that targeted individualized perioperative fluid management would improve postoperative ileus in patients receiving radical cystectomy.MethodsThis is a parallel-arm, double-blinded, single-center randomized trial of goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy. The primary outcome was postoperative ileus, and the secondary outcome was complications within 30 days post-surgery. Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation. The intervention in the goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring.ResultsBetween August 2014 and April 2018, 283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy) were included in the analysis. Postoperative ileus occurred in 25% (36 of 142) of patients in the goal-directed fluid therapy arm and 21% (30 of 141) of patients in the standard arm (difference in proportions, 4.1%; 95% CI, -5.8 to 13.9; P = 0.418). There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).ConclusionsGoal-directed fluid therapy may not be an effective strategy for lowering the risk of postoperative ileus in patients undergoing open radical cystectomy.

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:BackgroundPerioperative goal-directed fluid therapy (GDFT) aiming to maintain individual fluid balance based on sensitive parameters was prevalent in major surgery, especially in enhanced recovery after surgery (ERAS) pathway. This meta-analysis was conducted for the purpose of evaluating whether GDFT impacts on occurrence of postoperative ileus and whether its application is worthwhile in gastrointestinal surgery.MethodsA systematic search of RCTs compared GDFT with other fluid management in patients undergoing gastrointestinal surgery from the PubMed, Web of Science, Embase, Cochrane Library databases was implemented. The primary outcome is incidence of postoperative ileus. Other outcome measures were length of hospital stay (LOS), postoperative morbidity and mortality. Subgroup analysis was planed a prior to verify the definite role of GDFT.Results12 trials consisted of 1836 patients were included in the final analysis. GDFT did not influence the occurrence of postoperative ileus (relative risk, RR 0.71, 95% confidence interval, CI 0.47-1.07, P = .10), with moderate heterogeneity (I = 29%, P = .16). No difference was found between GDFT and control groups in LOS (mean difference -0.17 days, 95% CI -0.73 to 0.39, P = .55), total complication rate (RR 0.92, 95% CI 0.81-1.05, P = .23), and 30-day mortality (RR 0.91, 95% CI 0.47-1.75, P = .77). In other secondary outcomes, only wound infection rate was lower in the GDFT group (RR 0.68, 95% CI 0.50-0.93, P = .02). When performed subgroup analysis, GDFT was superior in reduction ileus only when compared with standard therapy or in those outside ERAS.ConclusionsIt is possible that GDFT dose not affect the occurrence of postoperative ileus in gastrointestinal surgery. It scarcely influences postoperative morbidity and mortality as well. However, lower incidence of ileus is observed in GDFT group either outside ERAS or compared with standard fluid therapy. Probably, GDFT may not be necessary in the ERAS pathway or if a hybrid approach is adopted.

Project description:BackgroundPostoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients' postoperative quality of life, as well as health care costs.Methods/designThis is a multi-center, international, prospective, randomized trial in 380 patients undergoing major abdominal surgery including visceral, urological, and gynecological operations. Eligible patients will be randomly allocated to two treatment arms within the participating centers. Patients of the intervention group will be treated perioperatively following a specific hemodynamic therapy algorithm based on pulse-pressure variation (PPV) and individualized optimization of cardiac output assessed by pulse-contour analysis (ProAQT© device; Pulsion Medical Systems, Feldkirchen, Germany). Patients in the control group will be treated according to standard local care based on established basic hemodynamic treatment. The primary endpoint is a composite comprising the occurrence of moderate or severe postoperative complications or death within 28 days post surgery. Secondary endpoints are: (1) the number of moderate and severe postoperative complications in total, per patient and for each individual complication; (2) the occurrence of at least one of these complications on days 1, 3, 5, 7, and 28 in total and for every complication; (3) the days alive and free of mechanical ventilation, vasopressor therapy and renal replacement therapy, length of intensive care unit, and hospital stay at day 7 and day 28; and (4) mortality and quality of life, assessed by the EQ-5D-5L™ questionnaire, after 6 months.DiscussionThis is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality.Trial registrationTrial registration: NCT03021525 . Registered on 12 January 2017.

Dataset Information

Goal directed fluid therapy for major liver resection: A multicentre randomized controlled trial.

Background

Methods

Results

Conclusion

Publications

Goal directed fluid therapy for major liver resection: A multicentre randomized controlled trial.

Similar Datasets

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