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Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial.

ABSTRACT: BACKGROUND:Goal directed therapy (GDT) is able to improve mortality and reduce complications in selected high-risk patients undergoing major surgery. The aim of this study is to compare two different strategies of perioperative hemodynamic optimization: one based on optimization of preload using dynamic parameters of fluid-responsiveness and the other one based on estimated oxygen extraction rate (O2ER) as target of hemodynamic manipulation. METHODS:This is a multicenter randomized controlled trial. Adult patients undergoing elective major open abdominal surgery will be allocated to receive a protocol based on dynamic parameters of fluid-responsiveness or a protocol based on estimated O2ER. The hemodynamic optimization will be continued for 6?h postoperatively. The primary outcome is difference in overall postoperative complications rate between the two protocol groups. Fluids administered, fluid balance, utilization of vasoactive drugs, hospital length of stay and mortality at 28?day will also be assessed. DISCUSSION:As a predefined target of cardiac output (CO) or oxygen delivery (DO2) seems to be not adequate for every patient, a personalized therapy is likely more appropriate. Following this concept, dynamic parameters of fluid-responsiveness allow to titrate fluid administration aiming CO increase but avoiding fluid overload. This approach has the advantage of personalized fluid therapy, but it does not consider if CO is adequate or not. A protocol based on O2ER considers this second important aspect. Although positive effects of perioperative GDT have been clearly demonstrated, currently studies comparing different strategies of hemodynamic optimization are lacking. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04053595. Registered on 12/08/2019.

SUBMITTER: Carsetti A

PROVIDER: S-EPMC7165409 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial.

Carsetti Andrea A Amici Mirco M Bernacconi Tonino T Brancaleoni Paolo P Cerutti Elisabetta E Chiarello Marco M Cingolani Diego D Cola Luisanna L Corsi Daniela D Forlini Giorgio G Giampieri Marina M Iuorio Salvatore S Principi Tiziana T Tappatà Giuseppe G Tempesta Michele M Adrario Erica E Donati Abele A

BMC anesthesiology 20200418 1

<h4>Background</h4>Goal directed therapy (GDT) is able to improve mortality and reduce complications in selected high-risk patients undergoing major surgery. The aim of this study is to compare two different strategies of perioperative hemodynamic optimization: one based on optimization of preload using dynamic parameters of fluid-responsiveness and the other one based on estimated oxygen extraction rate (O<sub>2</sub>ER) as target of hemodynamic manipulation.<h4>Methods</h4>This is a multicente ...[more]

PMID: 32305061

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Project description:Background. Postoperative morbidity has immediate and delayed consequences for surgical patients, including excess risk of premature death. Capturing these data objectively and routinely in large electronic databases using tools such as the Postoperative Morbidity Survey (POMS) would offer tremendous clinical and translational potential. However, POMS has thus far only utilised prospective data collection by research staff. We hypothesised that retrospective data collection from routinely collated hospital data from paper and electronic charts, medical and nursing notes was non-inferior to prospective data collection requiring research staff capturing POMS-defined morbidity in real-time. Methods. Morbidity was recorded by a trained investigator as defined by POMS prospectively on postoperative days 3 and 7. Separately, an independent investigator blinded to prospectively acquired data retrospectively assessed the same patients' morbidity as defined by POMS criteria, using medical charts, nursing summaries and electronic data. Equivalence was accepted when the confidence limits for both modes of data collection fell completely inside the equivalence bounds, with the maximum equivalence difference (i.e., the largest value of the difference in sensitivities deemed to reach a conclusion of equivalence) set a priori at 0.2. Differences for confidence limits between retrospective and prospective data collection were based on Nam's RMLE method. The relationship between morbidity on postoperative day 3 as recorded by each data collection method on time to become morbidity free and length of hospital stay was compared using the log-rank test. Results. POMS data from 85 patients undergoing elective or emergency surgery were analyzed. At postoperative day 3, POMS-defined morbidity was similar regardless of whether data were collected prospectively or retrospectively (95% CI [-0.13-0.013]; p < 0.001). Non-inferiority for sensitivity was observed for all other POMS domains and timepoints. Time to become morbidity free Kaplan-Meier plots were indistinguishable between POMS obtained prospectively or retrospectively (hazard ratio: 1.09 (95% CI [0.76-1.57]); p = 0.33, log rank test). Similarly, the mode of data collection did not alter the association between early postoperative morbidity on postoperative day 3 and delayed hospital discharge. Conclusions. Postoperative morbidity as defined by the Post Operative Morbidity Survey can be assessed retrospectively. These data may therefore be easily captured using electronic patient record systems, thereby expanding the potential for bioinformatics approaches to generate new clinical and translational insights into recovery from surgery.

Project description:BACKGROUND:Functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) have been shown to be reliable predictors of fluid responsiveness in mechanically ventilated patients. Today, different minimally- and non-invasive hemodynamic monitoring systems measure functional hemodynamic parameters. Although some of these parameters are described by the same name, they differ in their measurement technique and thus may provide different results. We aimed to test the performance of seven functional hemodynamic parameters simultaneously in the same clinical setting. METHODS:Hemodynamic measurements were done in 30 cardiac surgery patients that were mechanically ventilated. Before and after a standardized intravenous fluid bolus, hemodynamics were measured by the following monitoring systems: PiCCOplus (SVVPiCCO, PPVPiCCO), LiDCOrapid (SVVLiDCO, PPVLiDCO), FloTrac (SVVFloTrac), Philips Intellivue (PPVPhilips) and Masimo pulse oximeter (pleth variability index, PVI). Prediction of fluid responsiveness was tested by calculation of receiver operating characteristic (ROC) curves including a gray zone approach and compared using Fisher's Z-Test. RESULTS:Fluid administration resulted in an increase in cardiac output, while all functional hemodynamic parameters decreased. A wide range of areas under the ROC-curve (AUC's) was observed: AUC-SVVPiCCO = 0.91, AUC-PPVPiCCO = 0.88, AUC-SVVLiDCO = 0.78, AUC-PPVLiDCO = 0.89, AUC-SVVFloTrac = 0.87, AUC-PPVPhilips = 0.92 and AUC-PVI = 0.68. Optimal threshold values for prediction of fluid responsiveness ranged between 9.5 and 17.5%. Lowest threshold values were observed for SVVLiDCO, highest for PVI. CONCLUSION:All functional hemodynamic parameters tested except for PVI showed that their use allows a reliable identification of potential fluid responders. PVI however, may not be suitable after cardiac surgery to predict fluid responsiveness. TRIAL REGISTRATION:NCT02571465 , registered on October 7th, 2015 (retrospectively registered).

Project description:BackgroundPhotoplethysmography with a digital sensor (ClearSight, Edwards Lifesciences, Irvine, CA, USA) connected to a dedicated monitor (EV 1000, Edwards Lifesciences) was recently proposed for use in performing hemodynamic optimization during surgery. The objective of this study is to evaluate the effect of photoplethysmography on the incidence of postoperative complications compared with the conventional hemodynamic algorithm, which uses mean arterial pressure.Methods/designThe hemodynamic optimization using photoplethysmography (PANEX3) trial is a monocentric, randomized, single-blind, controlled, two parallel arm, superiority trial, randomizing 160 patients with an intermediate risk of postoperative complications after colorectal surgery. Informed consent will be obtained from all participants. The hemodynamic optimization is conducted using a specified hemodynamic algorithm either with photoplethysmography (the photoplethysmography group) or with conventional mean arterial pressure (the control group). The anesthesiologist performed a 1:1 randomization the day before surgery using a scratch card, which is available 24/7. The randomization sequence is generated using permutated blocks. Both the patients and surgeons are blinded to the allocation group. The primary outcome is the incidence of at least one postoperative complication during the 30 days following surgery. Two independent experts, who were blinded to the group allocations, validate the complication for each patient using an a priori classification. The secondary outcomes are to study the total number of postoperative complications, the real length of hospital stays, and the postoperative mortality between each group.DiscussionThe PANEX3 trial is the first randomized controlled study conducted to investigate whether perioperative hemodynamic optimization using photoplethysmography during colorectal surgery could decrease the incidence of patients having at least one postoperative complication.Trial registrationClinicalTrials.gov Identifier: NCT02343601.

Dataset Information

Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial.

Publications

Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial.

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