Dataset Information

Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial.

ABSTRACT:

Introduction

Brain edema is the most frequent postoperative complication after brain tumor resection, especially in patients with high-grade glioma. However, the effect of SVV-based goal-directed fluid therapy (GDFT) on postoperative brain edema and the prognosis remain unclear.

Methods and analysis

This is a prospective, randomized, double-blinded, parallel-controlled trial aiming to observe whether stroke volume variation (SVV)-based GDFT could improve the postoperative brain edema in patients undergoing supratentorial high-grade gliomas compared with traditional fluid therapy. The patient will be given 3 ml/kg hydroxyethyl starch solution when the SVV is greater than 15% continuously for more than 5 min intraoperatively. The primary outcome will be postoperative cerebral edema volume on brain CT within 24 h.

Ethics and dissemination

This trial has been registered at ClinicalTrials.gov (NCT03323580) and approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (reference number: KY2017-067-02). The findings will be disseminated in peer-reviewed journals and presented at national or international conferences relevant to the subject fields.

Trial registration

ClinicalTrials.gov NCT03323580 (First posted: October 27, 2017; Last update posted: February 11, 2022).

SUBMITTER: Liu X

PROVIDER: S-EPMC9675213 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial.

Liu Xiaoyuan X Zhang Xingyue X Fan Yifang Y Li Shu S Peng Yuming Y

Trials 20221119 1

<h4>Introduction</h4>Brain edema is the most frequent postoperative complication after brain tumor resection, especially in patients with high-grade glioma. However, the effect of SVV-based goal-directed fluid therapy (GDFT) on postoperative brain edema and the prognosis remain unclear.<h4>Methods and analysis</h4>This is a prospective, randomized, double-blinded, parallel-controlled trial aiming to observe whether stroke volume variation (SVV)-based GDFT could improve the postoperative brain ed ...[more]

PMID: 36401274

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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:BackgroundThe effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery.MethodsThis prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded.ResultsPatients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150-300] vs 400 ml [290-500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05).ConclusionsFocused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications.Trial registrationChiCTR, ChiCTR1800018227 . Registered 6 September 2018 - Retrospectively registered.

Project description:BackgroundOur aim was to evaluate the influence of staged goal directed therapy (GDT) on postoperative pulmonary complications (PPCs), intraoperative hemodynamics and oxygenation in patients undergoing Mckeown esophagectomy.MethodsPatients were randomly divided into three groups, staged GDT group (group A, n = 56): stroke volume variation (SVV) was set at 8-10% during the one lung ventilation (OLV) stage and 8-12% during the two lung ventilation (TLV) stage, GDT group (group B, n = 56): received GDT with a target SVV of 8-12% During the entire surgical procedure, and control group (group C, n = 56): conventional fluid therapy was administered by mean arterial pressure (MAP), central venous pressure (CVP), and urine volume. The primary outcome was the incidence of postoperative pulmonary complications within Postoperative days (POD) 7. The secondary outcomes were postoperative lung ultrasound (LUS) B-lines artefacts (BLA) scoring, incidence of other complications, the length of hospital stay, intraoperative hemodynamic and oxygenation indicators included mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), cardiac output (CO), oxygenation index (OI), respiratory indices (RI), alveolar-arterial oxygen difference (Aa-DO2).ResultsPatients in group A and group B had a lower incidence of PPCs (7/56 vs. 17/56 and 9/56 vs. 17/56, p < 0.05), and a fewer B-lines score on postoperative ultrasound (4.61 ± 0.51 vs. 6.15 ± 0.74 and 4.75 ± 0.62 vs. 6.15 ± 0.74, p < 0.05) compared to group C. The CI, CO, MAP, and OI were higher in group A compared to group B and group C in the stage of thoracic operation. During the abdominal operation stage, patients in group A and group B had a better hemodynamic and oxygenation indicators than group C.ConclusionsIn comparison to conventional fluid therapy, intraoperative staged GDT can significantly reduce the incidence of postoperative pulmonary complications in patients undergoing McKeown esophagectomy, facilitating patient recovery. Compared to GDT, it can improve intraoperative oxygenation and stabilize intraoperative hemodynamics in patients.Trial registrationThis study was registered in the Chinese Clinical Trial Registry on 24/11/2021 (ChiCTR2100053598).

Project description:BackgroundPulmonary complications after thoracic surgery are common and associated with significant morbidity and high cost of care. Goal-directed fluid therapy (GDFT) could reduce the incidence of postoperative pulmonary complications (PPCs) and facilitate recovery in patients undergoing major abdominal surgery. However, whether GDFT could reduce the incidence of PPCs in patients undergoing thoracic surgery was unclear. The present meta-analysis was designed to assess the impact of Goal-directed Fluid Therapy on PPCs in patients undergoing thoracic surgery.MethodsRandomized controlled trials (RCTs) comparing GDFT with other conventional fluid management strategies in adult patients undergoing thoracic surgery were identified. Databases searched included PubMed, Web of Science, Embase, and Cochrane Library databases. Review Manager 5.4 (The Cochrane Collaboration, Oxford, UK) software was used for statistical analysis. Heterogeneity was analyzed using I2 statistics, and a standardized mean difference with 95% CI and P value was used to calculate the treatment effect for outcome variables. The primary study outcomes were the incidence of PPCs. Secondary outcomes were the total volume infused, the length of hospitalization, the incidence of cardiac complications, and the incidence of renal dysfunction. Subgroup analysis was planned to verify the definite role of GDFT.ResultsA total of 6 RCTs consisting of 680 patients were included in this meta-analysis, which revealed that GDFT did not reduce the incidence of PPCs in patients undergoing thoracic surgery (RR, 0.57; 95% CI 0.29-1.14). However, GDFT decreased the total intra-operative fluid input (MD, - 244.40 ml; 95% CI - 397.06 to - 91.74). There was no statistical difference in the duration of hospitalization (MD; - 1.31, 95% CI - 3.00 to 0.38), incidence of renal dysfunction (RR, 0.62; 95% CI 0.29-1.35), and incidence of cardiac complications (RR, 0.62; 95% CI 0.27-1.40).ConclusionsThe results of this meta-analysis indicate that GDFT did not reduce the postoperative incidence of pulmonary complications in individuals undergoing thoracic surgery. However, considering the small number of contributing studies, these results should be interpreted with caution.

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.

Dataset Information

Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Publications

Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial.

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