Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial

Kaufmann, Kai; Stein, Lothar; Bogatyreva, Lioudmila; Ulbrich, Felix; Kaifi, Jussuf T.; Hauschke, Dieter; Loop, Torsten; Goebel, Ulrich

doi:10.1093/bja/aew447

Cited by 47 publications

(53 citation statements)

References 44 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…00006961) on the 2 nd of February 2015 ( S1 File ). [ 14 ] This trial was conducted at the Department of Anesthesiology and Intensive Care and the Department of Thoracic Surgery, Medical Center–University of Freiburg, Faculty of Medicine, University of Freiburg, Germany ( S2 File ).…”

Section: Methodsmentioning

confidence: 99%

“…Postoperative complications were recorded within 30 days after surgery and defined as reported previously: pulmonary complications including atelectasis, pneumonia, pleural empyema, respiratory failure, pulmonary embolism and bronchopleural fistula that required reoperation. [ 6 , 14 , 15 ] Cardiac and renal complications included myocardial infarction, new onset of atrial fibrillation and acute kidney injury according to the Acute Kidney Injury Network criteria. [ 15 ] Neurological complications included stroke and delirium.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Perioperative cytokine profile during lung surgery predicts patients at risk for postoperative complications—A prospective, clinical study

et al. 2018

View full text Add to dashboard Cite

BackgroundPostoperative complications after lung surgery are frequent, having a detrimental effect on patients’ further course. Complications may lead to an increased length of hospital stay and cause additional costs. Several risk factors have been identified but it is still difficult to predict contemporary which patients are at risk. We hypothesized that patients who show an increased inflammatory response at the time of wound closure and 24 hours after surgery are at risk of postoperative complications within 30 days after surgery.MethodsPostoperative complications (pulmonary, cardiac, neurological and renal) of 96 patients scheduled for lung surgery at the Medical Center–University of Freiburg were analyzed in this prospective, clinical study. Blood samples for cytokine analysis (Interleukin (IL)-6, IL-8, IL-10, Tumor necrosis factor [TNF]-α, IL-1ß and IL12p70) were taken before surgery, at wound closure and 24 hours after surgery. Cytokine levels of patients with and without postoperative complications were analyzed by Receiver operating characteristic (ROC) curve analysis. To adjust the results according to existing covariates a multivariate logistic regression analysis was conducted.ResultsThe complication and non-complication group differed significantly according to nicotine dependency, Angiotensin-receptor-II blocker medication, rate of thoracotomy and preoperative lung function. The intraoperative hemodynamic parameters and therapy did not differ between the groups. Twenty-nine patients (30%) developed postoperative complications within 30 days after surgery. Plasma concentrations of IL-6, IL-10 and IL-8 at the time of wound closure and 24 hours after surgery were higher in the complication group. Multivariate regression analysis on postoperative complications revealed an Odds ratio of 56 for patients with IL-6 and IL-8 levels above the 3rd quartile measured on the first postoperative day.ConclusionsPerioperative detection of increased plasma concentrations of inflammatory cytokines in lung surgery may be used in addition to other clinical predictors to identify patients at risk for postoperative complications.Trial registrationGerman Clinical Trials Register 00006961.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Perioperative cytokine profile during lung surgery predicts patients at risk for postoperative complications—A prospective, clinical study

et al. 2018

View full text Add to dashboard Cite

show abstract

“…In contrast to these studies we did not use colloids to optimize stroke volume due to several known side effects caused by liberal administration. In accordance with current literature we used a combination of goal-directed fluid therapy and inotropic medication instead of single goal-directed fluid therapy [ 13 , 14 , 28 – 30 ]. Data on EDM-guided goal-directed fluid therapy in orthopedic surgery showed promising results with regards to length of hospital stay [ 10 , 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, these studies did not focus on the incidence of BCIS. The Enhanced Recovery after Surgery (ERAS®) Society developed an evidence-based algorithm for goal-directed hemodynamic management which includes monitoring of cardiac output and optimization of stroke volume [ 13 , 14 ]. Different hemodynamic monitoring methods (e.g., pulse contour method, pulmonary artery catheter, transesophageal echocardiography) have been used to guide individualized intraoperative management [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of hemodynamic goal-directed therapy to reduce the incidence of bone cement implantation syndrome in patients undergoing cemented hip arthroplasty – a randomized parallel-arm trial

et al. 2018

View full text Add to dashboard Cite

BackgroundThe bone cement implantation syndrome (BCIS) is a frequent and potentially disastrous intraoperative complication in patients undergoing cemented hip arthroplasty. Several risk factors have been identified, however randomized controlled trials to reduce the incidence of BCIS are still pending. We hypothesized that goal-directed hemodynamic therapy guided by esophageal Doppler monitoring (EDM) may reduce the incidence of BCIS in a randomized, controlled parallel-arm trial.MethodsAfter approval of the local ethics committee, 90 patients scheduled for cemented hip arthroplasty at the Medical Center – University of Freiburg were randomly assigned to either standard hemodynamic management or goal-directed therapy (GDT) guided by an esophageal Doppler monitoring-based algorithm. The primary endpoint was the incidence of overall BCIS including grade 1–3 after cementation of the femoral stem. Secondary endpoints included cardiac function, length of hospital stay and postoperative complications.ResultsNinety patients were finally analyzed. With regards to the primary endpoint, the overall incidence of BCIS showed no difference between the GDT and control group. Compared to the control group, patients of the GDT group showed a higher cardiac index before and after bone cement implantation (2.7 vs. 2.2 [l●min− 1●m− 2]; 2.8 vs. 2.4 [l●min− 1●m− 2]; P = 0.003, P = 0.042), whereas intraoperative amount of fluids and mean arterial pressure did not differ.ConclusionsThe implementation of a specific hemodynamic goal-directed therapy did not reduce the overall incidence of BCIS in patients undergoing cemented hip arthroplasty.Trial registrationThis randomized clinical two-arm parallel study was approved by the local Ethics Committee, Freiburg, Germany [EK 160/15, PI: U. Goebel] and registered in the German Clinical Trials Register (DRKS No. 00008778, 16th of June, 2015).

show abstract

“…In this context hemodynamic goal-directed therapy, focusing on an optimization of fluid status and cardiac output, is believed to have the ability to reduce postoperative complications. Since methods like thermodilution, arterial pulse-contour analysis or esophageal Doppler allow routine measurement of cardiac output, several single-center studies have brought up the first evidence that perioperative, algorithm-driven optimization of cardiac output can reduce postoperative complications and improve outcome [ 7 – 11 ]. Also meta-analyses have demonstrated a reduction of morbidity in patients undergoing high-risk surgery [ 12 – 17 ].…”

Section: Introductionmentioning

confidence: 99%

Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial

Funcke

Saugel

Koch

et al. 2018

Trials

View full text Add to dashboard Cite

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2620-9) contains supplementary material, which is available to authorized users.

show abstract

Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial

Abstract: The study was registered in the German Clinical Trials Register (DRKS 00006961). https://drks-neu.uniklinik-freiburg.de/drks_web/.

Cited by 47 publications

References 44 publications

Perioperative cytokine profile during lung surgery predicts patients at risk for postoperative complications—A prospective, clinical study

Perioperative cytokine profile during lung surgery predicts patients at risk for postoperative complications—A prospective, clinical study

Evaluation of hemodynamic goal-directed therapy to reduce the incidence of bone cement implantation syndrome in patients undergoing cemented hip arthroplasty – a randomized parallel-arm trial

Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial

Contact Info

Product

Resources

About