Dataset Information

Efficacy and Safety of Stroke Volume Variation-Guided Fluid Therapy for Reducing Blood Loss and Transfusion Requirements During Radical Cystectomy: A Randomized Clinical Trial.

ABSTRACT: Radical cystectomy, which is performed to treat muscle-invasive bladder tumors, is among the most difficult urological surgical procedures and puts patients at risk of intraoperative blood loss and transfusion. Fluid management via stroke volume variation (SVV) is associated with reduced intraoperative blood loss. Therefore, we evaluated the efficacy and safety of SVV-guided fluid therapy for reducing blood loss and transfusion requirements in patients undergoing radical cystectomy.This study included 48 patients who underwent radical cystectomy, and these patients were randomly allocated to the control group and maintained at <10% SVV (n?=?24) or allocated to the trial group and maintained at 10% to 20% SVV (n?=?24). The primary endpoints were comparisons of the amounts of intraoperative blood loss and transfused red blood cells (RBCs) between the control and trial groups during radical cystectomy. Intraoperative blood loss was evaluated through the estimated blood loss and estimated red cell mass loss. The secondary endpoints were comparisons of the postoperative outcomes between groups.A total of 46 patients were included in the final analysis: 23 patients in the control group and 23 patients in the trial group. The SVV values in the trial group were significantly higher than in the control group. Estimated blood loss, estimated red cell mass loss, and RBC transfusion requirements in the trial group were significantly lower than in the control group (734.3?±?321.5?mL vs 1096.5?±?623.9?mL, P?=?0.019; 274.1?±?207.8?mL vs 553.1?±?298.7?mL, P?<0.001; 0.5?±?0.8 units vs 1.9?±?2.2 units, P?=?0.005). There were no significant differences in postoperative outcomes between the two groups.SVV-guided fluid therapy (SVV maintained at 10%-20%) can reduce blood loss and transfusion requirements in patients undergoing radical cystectomy without resulting in adverse outcomes. These findings provide useful information for optimal fluid management during radical cystectomy.

SUBMITTER: Kong YG

PROVIDER: S-EPMC4902548 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Stroke Volume Variation-Guided Fluid Therapy for Reducing Blood Loss and Transfusion Requirements During Radical Cystectomy: A Randomized Clinical Trial.

Kong Yu-Gyeong YG Kim Ji Yoon JY Yu Jihion J Lim Jinwook J Hwang Jai-Hyun JH Kim Young-Kug YK

Medicine 20160501 19

Radical cystectomy, which is performed to treat muscle-invasive bladder tumors, is among the most difficult urological surgical procedures and puts patients at risk of intraoperative blood loss and transfusion. Fluid management via stroke volume variation (SVV) is associated with reduced intraoperative blood loss. Therefore, we evaluated the efficacy and safety of SVV-guided fluid therapy for reducing blood loss and transfusion requirements in patients undergoing radical cystectomy.This study in ...[more]

PMID: 27175706

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Project description:Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk.To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques.A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively.Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach.Primary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score.The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings.This trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique.Of 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups.ClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.

Project description:Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data). Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57-621.94 ml), 250.30 ml postoperatively (95% CI, 35.31-465.30), and 601.40 ml overall (95% CI, 306.64-896.16 ml). The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30-754.67 ml). The transfusion rate was 44.6% (108/242) in the patients with antifibrinolytic agents and 68.3% (142/208) in the patients with placebo. (OR 0.38; 95% CI; 0.25-0.58; P<0.00001, I2 = 9%). All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group).The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements in scoliosis surgery. There was no evidence that the use of antifibrinolytic agents was a risk factor for adverse events, especially thromboembolism, in scoliosis 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.

Dataset Information

Efficacy and Safety of Stroke Volume Variation-Guided Fluid Therapy for Reducing Blood Loss and Transfusion Requirements During Radical Cystectomy: A Randomized Clinical Trial.

Publications

Efficacy and Safety of Stroke Volume Variation-Guided Fluid Therapy for Reducing Blood Loss and Transfusion Requirements During Radical Cystectomy: A Randomized Clinical Trial.

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