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Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial.

ABSTRACT: We aimed to evaluate perioperative outcomes in patients undergoing pancreaticoduodenectomy with or without a cardiac output goal directed therapy (GDT) algorithm. We conducted a multicentre randomised controlled trial in four high volume hepatobiliary-pancreatic surgery centres. We evaluated whether the additional impact of a intraoperative fluid optimisation algorithm would influence the amount of fluid delivered, reduce fluid related complications, and improve length of hospital stay. Fifty-two consecutive adult patients were recruited. The median (IQR) duration of surgery was 8.6 hours (7.1:9.6) in the GDT group vs. 7.8 hours (6.8:9.0) in the usual care group (p = 0.2). Intraoperative fluid balance was 1005mL (475:1873) in the GDT group vs. 3300mL (2474:3874) in the usual care group (p<0.0001). Total volume of fluid administered intraoperatively was also lower in the GDT group: 2050mL (1313:2700) vs. 4088mL (3400:4525), p<0.0001 and vasoactive medications were used more frequently. There were no significant differences in proportions of patients experiencing overall complications (p = 0.179); however, fewer complications occurred in the GDT group: 44 vs. 92 (Incidence Rate Ratio: 0.41; 95%CI 0.24 to 0.69, p = 0.001). Median (IQR) length of hospital stay was 9.5 days (IQR: 7.0, 14.3) in the GDT vs. 12.5 days in the usual care group (IQR: 9.0, 22.3) for an Incidence Rate Ratio 0.64 (95% CI 0.48 to 0.85, p = 0.002). In conclusion, using a surgery-specific, patient-specific goal directed restrictive fluid therapy algorithm in this cohort of patients, can justify using enough fluid without causing oedema, yet as little fluid as possible without causing hypovolaemia i.e. "precision" fluid therapy. Our findings support the use of a perioperative haemodynamic optimization plan that prioritizes preservation of cardiac output and organ perfusion pressure by judicious use of fluid therapy, rational use of vasoactive drugs and timely application of inotropic drugs. They also suggest the need for further larger studies to confirm its findings.

SUBMITTER: Weinberg L

PROVIDER: S-EPMC5589093 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFindings of observational studies investigating the impact of transfusions are at odds with those of randomised controlled trials, raising concern that observational studies may be inappropriate to inform transfusion decisions. We examined whether observational data could replicate evidence from randomised controlled trials on restrictive transfusion in cardiac and orthopaedic surgery, and be generalised to broader specialties as well as to a lower haemoglobin transfusion threshold (7 g/dL).Material and methodsA multicentre, prospective cohort study was performed at three representative regional hospitals in China between 2015 and 2016. Participants were surgical inpatients (≥18 years; hospital stay ≥24 h) in six specialties: cardiac, cerebral, vascular (CCV), and orthopaedic, general, thoracic (non-CCV). Patients with a stable haemoglobin (7-10 g/dL) constituted the primary analytic sample, while patients with ≥500 mL intra-operative bleeding were analysed separately to avoid haemoglobin instability. The association of transfusion with surgical outcomes (death, in-hospital complications) was evaluated.ResultsThe transfusion rate was 10.7% in 36,607 patients (mean age, 52.5±14.3 years; 52.3% female). After restriction, stratification, and propensity score matching to reduce patients' heterogeneity, transfusion was unrelated to death (CCV: odds ratio [OR]=0.74, 95% confidence interval [CI]: 0.16-3.39; non-CCV: OR 0.83, 95% CI: 0.36-1.94) and the composite complication (CCV: OR 1.31, 95% CI: 0.63-2.72; non-CCV: OR=1.24, 95% CI: 0.81-1.90). The results were consistent in subgroups (elderly, coronary heart disease, malignant tumour, severe illness) and applicable to patients with significant bleeding after restoration of a stable haemoglobin.DiscussionTransfusion at a stable haemoglobin concentration of 7-10 g/dL did not alter surgical outcomes. Our results show the feasibility of observational data to expand restrictive transfusion to broader specialties and a lower transfusion threshold in surgical practice.

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:ObjectiveTo prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events.DesignInternational, multicentre cohort study.Setting18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America.ParticipantsThe cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres.Main outcome measuresIntraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications.ResultsOf 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%).ConclusionsClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients.Trial registrationClinicalTrials.gov NCT03009929.

Project description:BackgroundAcute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid infusion strategy; the fluid infusion strategy is adjusted according to the patient's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) protocol optimizes perioperative interventions to decrease the postoperative complications after surgery. In ERAS protocol of lobectomy, intraoperative restrictive fluid therapy is recommended. In this study, we will compare the effects of intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients.Methods/designThis is a prospective single-center single-blind randomized controlled trial. Two hundred seventy-six patients scheduled for thoracoscopic lobectomy are randomly allocated to receive either GDFT or restrictive fluid therapy combined with an ERAS protocol at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes include (1) the incidence of renal replacement therapy, (2) the length of intensive care unit stay after operation, (3) the length of hospital stay after operation, and (4) the incidence of other complications including infection, acute lung injury, pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery, and cardiac infarction.DiscussionThis is the first study to compare intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients. The hypothesis is that the restrictive fluid therapy is noninferior to GDFT in reducing the incidence of AKI, but restrictive fluid therapy is simpler to apply than GDFT.Trial registrationClinicalTrials.gov NCT04302467 . Registered on 26 February 2020.

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Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial.

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