Perioperative restrictive versus goal-directed fluid therapy for adults undergoing major non-cardiac surgery.
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ABSTRACT:
SUBMITTER: Wrzosek A
PROVIDER: S-EPMC6953415 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAlthough goal-directed fluid therapy (GDFT) is associated with reduced morbidity and length of stay (LOS) in the hospital after major surgery, it has not been widely studied in ovarian cancer cytoreductive surgery (CRS). The primary objective of the study was post-operative LOS.MethodsIn this double-blind, randomised controlled trial, ovarian cancer patients undergoing elective CRS were randomised to receive either GDFT or restrictive fluid therapy after pre-randomisation stratification for primary debulking surgery or interval debulking surgery. The primary objective was to measure post-operative LOS in the hospital. Secondary outcome measures were the cost of surgical treatment episode and post-operative morbidity assessed by post-operative morbidity survey (POMS) on the 1st, 3rd, 5th, and 7th post-operative day and at discharge. Clavien-Dindo (CD) classification was used to assess the 30-day morbidity/mortality rate.ResultsMedian LOS was 7 days (interquartile range (IQR): 5-10; P = 0.282) in both groups. Median POMS at day 3 was 3 (IQR: 2-5) in the GDFT and 4 (IQR: 2.25-2.75) in the control groups (P = 0.625). The cost of treatment was INR 310907 (IQR: INR 211,856-427,490) in the GDFT group and INR 342,468 (IQR: INR 270,179-454,122) in the control group (P = 0.100). Grade 3-5 CD morbidity was 7 (12%) in GDFT and 9 (16%) in the control group (P = 0.790).ConclusionGDFT did not confer significant benefit over restrictive fluid therapy in ovarian cancer CRS regarding hospital LOS.
| S-EPMC10858687 | biostudies-literature
Project description:IntroductionCardiac surgery patients are at increased risk for post-operative complications and prolonged length of stay. Perioperative goal directed therapy (GDT) has demonstrated utility for non-cardiac surgery, however, GDT is not common for cardiac surgery. We initiated a quality improvement (QI) project focusing on the implementation of a GDT protocol, which was applied from the immediate post-bypass period into the intensive care unit (ICU). Our hypothesis was that this novel GDT protocol would decrease ICU length of stay and possibly improve postoperative outcomes.MethodsThis was a historical prospective, QI study for patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB). Integral to the QI project was education towards all associated providers on the concepts related to GDT. The protocol involved identifying patient specific targets for cardiac index and mean arterial pressure. These targets were maintained from the post-CPB period to the first 12 h in the ICU. Statistical comparisons were performed between the year after GDT therapy was launched to the last two years prior to protocol implementation. The primary outcome was ICU length of stay.ResultsThere was a significant decrease in ICU length of stay when comparing the year after the protocol initiation to years prior, from a median of 6.19 days to 4 days (2017 vs. 2019, p < 0.0001), and a median of 5.88 days to 4 days (2018 vs. 2019, p < 0.0001). Secondary outcomes demonstrated a significant reduction in total administered volumes of inotropic medication(milrinone). All other vasopressors demonstrated no differences across years. Hospital length of stay comparisons did not demonstrate a significant reduction.ConclusionThese results suggest that an individualized goal directed therapy for cardiac surgery patients can reduce ICU length of stay and decrease amount of inotropic therapy.
| S-EPMC7864512 | biostudies-literature
Project description:BackgroundPostoperative complications impact on early and long-term patients' outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. We conducted this trial to address the impact of restrictive vs. liberal fluid approaches on overall postoperative complications and mortality.MethodsSystematic review and meta-analysis, including randomised controlled trials (RCTs). We performed a systematic literature search using MEDLINE (via Ovid), EMBASE (via Ovid) and the Cochrane Controlled Clinical trials register databases, published from 1 January 2000 to 31 December 2019. We included RCTs enrolling adult patients undergoing elective abdominal surgery and comparing the use of restrictive/liberal approaches enrolling at least 15 patients in each subgroup. Studies involving cardiac, non-elective surgery, paediatric or obstetric surgeries were excluded.ResultsAfter full-text examination, the metanalysis finally included 18 studies and 5567 patients randomised to restrictive (2786 patients; 50.0%) or liberal approaches (2780 patients; 50.0%). We found no difference in the occurrence of severe postoperative complications between restrictive and liberal subgroups [risk difference (95% CI) = 0.009 (- 0.02; 0.04); p value = 0.62; I2 (95% CI) = 38.6% (0-66.9%)]. This result was confirmed also in the subgroup of five studies having a low overall risk of bias. The liberal approach was associated with lower overall renal major events, as compared to the restrictive [risk difference (95% CI) = 0.06 (0.02-0.09); p value = 0.001]. We found no difference in either early (p value = 0.33) or late (p value = 0.22) postoperative mortality between restrictive and liberal subgroups CONCLUSIONS: In major abdominal elective surgery perioperative, the choice between liberal or restrictive approach did not affect overall major postoperative complications or mortality. In a subgroup analysis, a liberal as compared to a restrictive perioperative fluid policy was associated with lower overall complication renal major events, as compared to the restrictive.Trial registrationCRD42020218059; Registration: February 2020, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=218059 .
| S-EPMC8194047 | biostudies-literature
Project description:IntroductionThe plethysmographic variability index (PVI) is a dynamic approach for assessing volume status. This study aims to compare conventional fluid management and PVI based goal-directed fluid management (GDFM) during elective spine surgery in the prone position.Material and methodsSixty-six adult patients, ASA I-II, scheduled for elective lumbar spine procedures under general anaesthesia in the prone position were included. Patients were randomly divided into either the Conventional Group with the conventional fluid management protocol or the PVI Group with the PVI-based GDFM protocol. The total amount of intraoperative crystalloid administered was set as a primary outcome. Intraoperative PVI and perfusion index (PI), mean arterial pressure (MAP), heart rate (HR), the incidence of hypotension after prone positioning in both groups and data from arterial blood gas samples (immediately after induction of anaesthesia [T1] and immediately postoperatively [T2]) were set as secondary outcomes.ResultsThe total amount of intraoperative crystalloids, blood transfusion, urine output, and fluid balance were similar in the two groups ( P -values 0.443, 0.317 and 0.273, respectively). The perioperative MAP and HR values showed no significant differences between the two groups at all time points of measurements. The values of pH, PaO 2 , PaCO 2 , HCO 3 , lactate and haemoglobin showed no statistically significant difference between the two groups. The blood lactate value at T2 was significantly increased when compared to T1 values in the two groups.ConclusionsPVI dependent goal-directed fluid management (GDFM) therapy did not reduce the intraoperative total crystalloid administration or requirements for blood transfusion when compared to conventional fluid management using a fixed fluid rate in patients undergoing spine surgery in a prone position. Clinical trial registration: The study was registered at clinicaltrials.gov (NCT05239286).
| S-EPMC10496101 | biostudies-literature
Project description:Intravascular fluid administration belongs to the cornerstones of perioperative treatment with a substantial impact on surgical outcome especially with respect to major abdominal surgery. By avoidance of hypovolemia and hypervolemia, adequate perioperative fluid management significantly contributes to the reduction of insufficient tissue perfusion as a determinant of postoperative morbidity and mortality. The effective use of intravascular fluids requires detailed knowledge of the substances as well as measures to guide fluid therapy. Fluid management already starts preoperatively and should be continued in the postoperative setting (recovery room, peripheral ward) considering a patient-adjusted and surgery-adjusted hemodynamic monitoring. Communication between all team members participating in perioperative care is essential to optimize fluid management.
| S-EPMC7851019 | biostudies-literature
Project description:BackgroundIntraoperative fluid management is important for the prevention of perioperative morbidity and mortality. Our study aimed to investigate the perioperative feasibility and benefits of Goal-Directed Fluid Management (GDFM) using noninvasive hemodynamic monitoring in gynecologic oncology patients with acute blood loss and severe fluid loss. We assessed the effects of GDFM on hemodynamics, organ perfusion, complications, and mortality outcomes.MethodsThis randomized prospective study included 104 patients over the age of 18 years, including 56 patients with endometrial cancer and 48 patients with ovarian cancer who had open surgery. The anesthetic approach was standardized for all patients. We compared the perioperative results of the subjects who were randomized into GDFM (n = 51) and Liberal Fluid Management (LFM) (n = 53) groups using a computer program.ResultsThe median perioperative crystalloid replacement (2000 vs. 2700; p < 0.001) and total volume of fluid (2260 vs. 3200; p < 0.001) were lower in the GDFM group compared to the LFM group. The hemodynamic findings and the HCO3 and lactate levels of the GDFM group did not significantly change perioperatively. The heart rate, mean arterial pressure, and HCO3 levels of the LFM group decreased and serum lactate levels increased perioperatively. The hospitalization rate in ICU (7.8% vs. 28.3%; p = 0.010), rate of patients with comorbidity conditions indicated in ICU (2% vs. 17%; p = 0.024), and rate of complications (17.6% vs. 35.8%; p = 0.047) were lower in the GDFM group compared to the LFM group.ConclusionThe amount of intraoperatively administered crystalloid solution and complication rates were significantly lower in gynecologic oncologic surgery patients who received GDFM. Besides, hemodynamic findings, and lactate levels of the GDFM group did not change significantly during the perioperative period.
| S-EPMC9373248 | biostudies-literature
Project description:BackgroundIntraoperative goal-directed fluid therapy (GDFT) is recommended in most perioperative guidelines for intraoperative fluid management in patients undergoing elective colorectal surgery. However, the evidence in elective colorectal surgery alone is not well established. The aim of this meta-analysis was to compare the effects of GDFT with those of conventional fluid therapy on outcomes after elective colorectal surgery.MethodsA meta-analysis of RCTs examining the role of transoesophageal Doppler-guided GDFT with conventional fluid therapy in adult patients undergoing elective colorectal surgery was performed in accordance with PRISMA methodology. The primary outcome measure was overall morbidity, and secondary outcome measures were length of hospital stay, time to return of gastrointestinal function, 30-day mortality, acute kidney injury, and surgical-site infection and anastomotic leak rates.ResultsA total of 11 studies were included with a total of 1113 patients (556 GDFT, 557 conventional fluid therapy). There was no significant difference in any clinical outcome measure studied between GDFT and conventional fluid therapy, including overall morbidity (risk ratio (RR) 0·90, 95 per cent c.i. 0·75 to 1·08, P = 0·27; I 2 = 47 per cent; 991 patients), 30-day mortality (RR 0·67, 0·23 to 1·92, P = 0·45; I 2 = 0 per cent; 1039 patients) and length of hospital stay (mean difference 0·01 (95 per cent c.i. -0·92 to 0·94) days, P = 0·98; I 2 = 34 per cent; 1049 patients).ConclusionThis meta-analysis does not support the perceived benefits of GDFT guided by transoesophageal Doppler monitoring in the setting of elective colorectal surgery.
| S-EPMC6773648 | biostudies-literature
Project description:BackgroundPerioperative fluid therapy is used to avoid dehydration and hypovolemia. Optimum perioperative fluid administration may improve postoperative outcomes after major surgery, and the optimal strategy remains controversial and uncertain.AimsThe primary outcome was the total amount of intraoperative fluids given between perioperative goal-directed fluid therapy (GDFT) guided by a hemodynamic monitoring system and standard fluid therapy based on “mean arterial pressure-diuresis” data in patients undergoing head and neck surgery. The secondary outcomes were the hemodynamics and laboratory variables, postoperative complications, length of mechanical ventilation, intensive care unit and hospital stay.Study designA randomized controlled study.MethodsSixty patients were scheduled and randomized into two groups of 30 patients each: in the study group, an arterial pressure catheter was inserted and connected to the FloTrac system, whereas in the control group, an arterial pressure catheter was inserted and integrated into the hemodynamic monitoring system with a special transducer. The control group had fluids administered at the discretion of the anesthesiologist according to the mean arterial pressure >65 mmHg and diuresis >0.5 ml/kg/h. In the study group, fluid management was administered to achieve a target value of ≤13% through the stroke volume variation.ResultsThe total amounts of fluid in the intraoperative period were different between the groups, with the study group receiving significantly more fluids (P = 0.0455). The length of hospital stay was significantly longer in the study group than in the control group (P = 0.012), but prolonged oxygen demand was significantly more frequent in the control group than in the study group (P = 0.017). No difference was found in hemodynamics, lactate kinetics, and vasoactive agent requirements.ConclusionThe standard fluid therapy guided by conventional circulatory parameters appears sufficient for patients with low-tomoderate risk during head and neck surgery.
| S-EPMC9469670 | biostudies-literature
Project description:ObjectivesTo compare the effects of intraoperative goal-directed fluid therapy (GDFT) with conventional fluid therapy, and determine whether there was a difference in outcome between studies that did and did not use Enhanced Recovery After Surgery (ERAS) protocols.MethodsMeta-analysis of randomized controlled trials of adult patients undergoing elective major abdominal surgery comparing intraoperative GDFT versus conventional fluid therapy. The outcome measures were postoperative morbidity, length of stay, gastrointestinal function and 30-day mortality.ResultsA total of 23 studies were included with 2099 patients: 1040 who underwent GDFT and 1059 who received conventional fluid therapy. GDFT was associated with a significant reduction in morbidity (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.66-0.89, P?=?0.0007), hospital length of stay (LOS; mean difference -1.55 days, 95% CI -2.73 to -0.36, P?=?0.01), intensive care LOS (mean difference -0.63 days, 95% CI -1.18 to -0.09, P?=?0.02), and time to passage of feces (mean difference -0.90 days, 95% CI -1.48 to -0.32 days, P?=?0.002). However, no difference was seen in mortality, return of flatus, or risk of paralytic ileus. If patients were managed in an ERAS pathway, the only significant reductions were in intensive care LOS (mean difference -0.63 days, 95% CI -0.94 to -0.32, P?<?0.0001) and time to passage of feces (mean difference -1.09 days, 95% CI -2.03 to -0.15, P?=?0.02). If managed in a traditional care setting, a significant reduction was seen in both overall morbidity (RR 0.69, 95% CI 0.57 to -0.84, P?=?0.0002) and total hospital LOS (mean difference -2.14, 95% CI -4.15 to -0.13, P?=?0.04).ConclusionsGDFT may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in an ERAS setting.
| S-EPMC4741406 | biostudies-literature
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.
| S-EPMC5944092 | biostudies-literature