Dataset Information

Assessment of early goal-directed therapy guideline adherence: Balancing clinical importance and feasibility.

ABSTRACT:

Background

Assessing adherence to Early goal-directed therapy (EGDT) is challenging and might account for the negative findings and generalisability of the major trials to a real-life setting. This study was aimed (1) to extract key components of pediatric EGDT guidelines potentially becoming adherence criteria; (2) to classify adherence criteria into complete, clinically important, and feasible; and (3) to compare percent adherence to selected guidelines using the three approaches.

Methods

This study started with review of existing evidence to extract key components of pediatric EGDT guidelines. Modified Delphi method was then conducted in two rounds among national experts to identify feasible and/or clinically important criteria. Data from the national prospective multicenter study "Clinical Effectiveness of the Utilization of Bundled Care for Severe Sepsis and Septicemia Children" at King Chulalongkorn Memorial Hospital (KCMH) during 1 June 2012 and 28 February 2014 was used to compare percentage of adherence across the three approaches.

Results

Of 28 components extracted from the review, 10 were identified by the national experts through the Modified Delphi as feasible whereas 8 were identified as clinically important. Thirty-one severe sepsis patients (48.39% male, median age 3.4 years) were reviewed. Sepsis mortality was 9.7%, a significant reduction from 19% and 42% in 2010 and 2007, respectively. Based on the complete adherence criteria, the percent adherence varied from 60.71% to 89.29% (overall mean 76.84%), with lower adherence in the dead than the survived cases (73.81% vs 77.17%; p = 0.55). The percent adherence varied by criteria used: 69.35%, 76.84%, and 84.52% for clinical importance, complete, and feasibility criteria, respectively.

Conclusion

Adherence determination based on selected clinical importance alone might result in an incorrectly estimated clinical benefit of EGDT guidelines, especially in a resource-limited setting. Both clinical importance and feasibility should be integrated into the development of adherence assessment criteria.

SUBMITTER: Saetae T

PROVIDER: S-EPMC6420253 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Although beneficial effects of an early goal directed therapy (EGDT) after cardiac arrest and successful return of spontaneous circulation (ROSC) have been described, clinical implementation in this period seems rather difficult. The aim of the present study was to investigate the feasibility and the impact of EGDT on myocardial damage and function after cardiac resuscitation. A translational pig model which has been carefully adapted to the clinical setting was employed. After 8 min of cardiac arrest and successful ROSC, pigs were randomized to receive either EGDT (EGDT group) or therapy by random computer-controlled hemodynamic thresholds (noEGDT group). Therapeutic algorithms included blood gas analysis, conductance catheter method, thermodilution cardiac output and transesophageal echocardiography. Twenty-one animals achieved successful ROSC of which 13 pigs survived the whole experimental period and could be included into final analysis. cTnT and LDH concentrations were lower in the EGDT group without reaching statistical significance. Comparison of lactate concentrations between 1 and 8 h after ROSC exhibited a decrease to nearly baseline levels within the EGDT group (1 h vs 8 h: 7.9 vs. 1.7 mmol/l, P < 0.01), while in the noEGDT group lactate concentrations did not significantly decrease. The EGDT group revealed a higher initial need for fluids (P < 0.05) and less epinephrine administration (P < 0.05) post ROSC. Conductance method determined significant higher values for preload recruitable stroke work, ejection fraction and maximum rate of pressure change in the ventricle for the EGDT group. EGDT after cardiac arrest is associated with a significant decrease of lactate levels to nearly baseline and is able to improve systolic myocardial function. Although the results of our study suggest that implementation of an EGDT algorithm for post cardiac arrest care seems feasible, the impact and implementation of EGDT algorithms after cardiac arrest need to be further investigated.

Project description:ObjectiveEchocardiography is often used to guide septic shock resuscitation, but without evidence for efficacy. We conducted an intensive care unit (ICU)-based randomized controlled feasibility trial comparing echocardiography-guided septic shock resuscitation (ECHO) with early goal-directed therapy (EGDT).MethodsWe conducted a single center, randomized controlled feasibility trial at a 468-bed academic tertiary care center in Utah, USA. Adult patients with early septic shock were assessed and treated at defined intervals over 6 h using an echocardiogram-guided resuscitation protocol or a slightly modified EGDT protocol. Feasibility outcomes were fluid balance, dobutamine administration, and time to lactate clearance. The primary clinical outcome was changed in sequential organ failure assessment score at 48 h (delta SOFA). Secondary outcomes included inpatient mortality, ICU-free days, and ventilator-free days at 28 days.ResultsThirty participants, 15 per group, were randomized and completed the study. Baseline characteristics were similar between groups. Patients were randomized within a median of 3.5 h of meeting inclusion criteria but had received a median of 3 L crystalloid by then. Fluid administration during the study protocol was similar in both groups (median ECHO 0 vs EGDT 1 L, p = 0.61). Eleven (73%) subjects in each arm received ≤ 1 L fluid. Dobutamine administration was also similar (20% vs 13%, p > 0.99). Twenty-one patients (70%) had lactate clearance prior to the first study assessment. No difference was observed in delta SOFA (median - 4 for ECHO vs - 6 for EGDT, p = 0.10) nor mortality (33% ECHO vs 20% EGDT, p = 0.68).ConclusionsNo experimental separation was observed in this randomized, controlled feasibility trial. Early lactate clearance, coupled with substantial fluid administration before randomization, suggests that patients were already resuscitated before arrival in the ICU. Future trials of echocardiogram-guided sepsis resuscitation will likely need to enroll in the emergency department.Trial registrationThis study was retrospectively registered at clinicaltrials.gov (identifier NCT02354742, title Echo vs EGDT in severe sepsis and septic shock) on February 3, 2015. Registration was completed before review or analysis of any data.

Project description:ImportanceDepression is associated with increased risk of primary and secondary cardiovascular events. Medication adherence may play an essential role.ObjectiveTo evaluate the association of depression and 12-month adherence to guideline-directed medical therapies (eg, antiplatelet agents, β-blockers, renin-angiotensin-aldosterone system inhibitors [ie, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers], and statins) following percutaneous coronary intervention.Design, setting, and participantsThis retrospective cohort study included individuals who underwent percutaneous coronary intervention from January 1, 2014, to December 31, 2019. Data were collected from a large US health claims database and analyzed between February and August 2022.Main outcomes and measuresProportion of days covered (PDC) for classes of guideline-directed medical therapies, with 12-month adherence categorized as adequate (PDC ≥80% to <90%) or optimal (PDC ≥90%). Multivariable-adjusted regression models were used to evaluate the association of depression with adherence; models incorporated demographic characteristics, comorbid medical and psychiatric conditions, depression treatment, and guideline-directed medical therapy treatment adjustment. The hypothesis was that those with depression would have lower odds of either adequate or optimal adherence to agents essential for guideline-directed medical therapy.ResultsOf 124 443 individuals (mean [SD] age, 69.3 [10.6] years; 41 430 [33.3%] female sex; 3694 [3.0%] Asian, 12 611 [10.1%] Black, and 12 337 [9.9%] Hispanic individuals) who received percutaneous coronary interventions, 20 711 (16.6%) had a diagnosis of depression. Those with depression were significantly less likely to obtain adequate 12-month adherence to antiplatelets (odds ratio [OR], 0.80; 95% CI, 0.77-0.85), β-blockers (OR, 0.84; 95% CI, 0.80-0.88), and statins (OR, 0.88; 95% CI, 0.85-0.93) than those without depression; there was no association between depression and adherence to renin-angiotensin-aldosterone system inhibitors (OR, 0.93; 95% CI, 0.85-1.00). Those with depression had similarly decreased likelihood of optimal 12-month adherence to antiplatelets, β-blockers, and statins as well as renin-angiotensin-aldosterone system inhibitors (OR, 0.87; 95% CI, 0.82-0.94).Conclusions and relevanceIn this cohort study, patients with depression were less likely to achieve adequate or optimal adherence to medications essential to guideline-directed medical therapies following percutaneous coronary intervention compared with those without depression. Recognition of depression may facilitate targeted interventions to address medication adherence and thereby improve secondary cardiovascular disease prevention.

Project description:IntroductionSevere pneumonia is a crucial issue in the development of acute kidney injury (AKI). This study evaluated the efficacy of early goal-directed renal replacement therapy (GDRRT) for the treatment of severe pneumonia-associated AKI.MethodsIn this real-world retrospective cohort study, we recruited 180 patients with severe pneumonia who were hospitalized and received GDRRT in a third-class general hospital in East China between January 1, 2017, and December 31, 2021. Clinical data on baseline characteristics, biochemical indicators, and renal replacement therapy were collected. Patients were divided into Early and Late RRT groups according to fluid status, inflammation progression, and pulmonary radiology. We investigated in-hospital all-cause mortality (primary endpoint) and renal recovery (secondary endpoint) between the two groups.ResultsAmong the 154 recruited patients, 80 and 74 were in the early and late RRT groups, respectively. There were no significant differences in the demographic characteristics between the two groups. The duration of admission to RRT initiation was significantly shorter in Early RRT group [2.5(1.0, 8.7) d vs. 5.0(1.5,13.5) d, p = 0.027]. At RRT initiation, the patients in the Early RRT group displayed a lower percentage of fluid overload, lower doses of vasoactive agents, higher CRP levels, and higher rates of radiographic progression than those in the Late RRT group. The all-cause in-hospital mortality was significantly lower in the Early RRT group than in Late group (52.5% vs. 86.5%, p < 0.001). Patients in the Early RRT group displayed a significantly higher proportion of complete renal recovery at discharge (40.0% vs. 8.1%, p < 0.001).ConclusionThis study clarified that early GDRRT for the treatment of severe pneumonia-associated AKI based on fluid status and inflammation progression, was associated with reduced hospital mortality and better recovery of renal function. Our preliminary study suggests that early initiation of RRT may be an effective approach for severe pneumonia-associated AKI.

Project description:BackgroundEarly goal-directed therapy (EGDT) has become an important therapeutic management in early salvage stage of septic shock. However, splenic organs possibly remained hypoperfused and hypoxic despite fluid resuscitation. This study aimed to evaluate the effect of EGDT on hepatic perfusion in septic shock patients.MethodsA prospective observational study was carried out in early septic shock patients who were admitted to Intensive Care Unit within 24 h after onset and who met all four elements of the EGDT criteria after treatment with the standard EGDT procedure within 6 h between December 1, 2012 and November 30, 2013. The hemodynamic data were recorded, and oxygen metabolism and hepatic functions were monitored. An indocyanine green clearance test was applied to detect the hepatic perfusion. The patients' characteristics were compared before treatment (T0), immediately after EGDT (T1), and 24 h after EGDT (T2). This study is registered at ClinicalTrials.org, NCT02060773.ResultsTwenty-one patients were included in the study; however, the hepatic perfusion data were not included in the analysis for two patients; therefore, 19 patients were eligible for the study. Hemodynamics data, as monitored by pulse-indicator continuous cardiac output, were obtained from 16 patients. There were no significant differences in indocyanine green plasma disappearance rate (ICG-PDR) and 15-min retention rate (R15) at T0 (11.9 ± 5.0%/min and 20.0 ± 13.2%), T1 (11.4 ± 5.1%/min and 23.6 ± 14.9%), and T2 (11.0 ± 4.5%/min and 23.7 ± 15.3%) (all P > 0.05). Both of the alterations of ICG-PDR and R15 showed no differences at T0, T1, and T2 in the patients of different subgroups that achieved different resuscitation goal numbers when elected (P > 0.05).ConclusionThere were no hepatic perfusion improvements after EGDT in the early phase of patients with septic shock.Trial registrationClinicaltrials.gov NCT02060773 (https://clinicaltrials.gov/ct2/show/NCT02060773).

Project description:Central venous catheterization (CVC) can be an important component of the management of patients with severe sepsis and septic shock. CVC, however, is a time- and resource-intensive procedure associated with serious complications. The effects of the absence of shock or the presence of relative contraindications on undertaking central line placement in septic emergency department (ED) patients eligible for early goal-directed therapy (EGDT) have not been well described. We sought to determine the association of relative normotension (sustained systolic blood pressure >90 mmHg independent of or in response to an initial crystalloid resuscitation of 20 mL/kg), obesity (body mass index [BMI] ≥30), moderate thrombocytopenia (platelet count <50,000 per μL), and coagulopathy (international normalized ratio ≥2.0) with unattempted CVC in EGDT-eligible patients.This was a retrospective cohort study of 421 adults who met EGDT criteria in 5 community EDs over a period of 13 months. We compared patients with attempted thoracic (internal jugular or subclavian) CVC with those who did not undergo an attempted thoracic line. We also compared patients with any attempted CVC (either thoracic or femoral) with those who did not undergo any attempted central line. We used multivariate logistic regression analysis to calculate adjusted odd ratios (AORs).In our study, 364 (86.5%) patients underwent attempted thoracic CVC and 57 (13.5%) did not. Relative normotension was significantly associated with unattempted thoracic CVC (AOR 2.6 95% confidence interval [CI], 1.6-4.3), as were moderate thrombocytopenia (AOR 3.9; 95% CI, 1.5-10.1) and coagulopathy (AOR 2.7; 95% CI, 1.3-5.6). When assessing for attempted catheterization of any central venous site (thoracic or femoral), 382 (90.7%) patients underwent attempted catheterization and 39 (9.3%) patients did not. Relative normotension (AOR 2.3; 95% CI, 1.2-4.5) and moderate thrombocytopenia (AOR 3.9; 95% CI, 1.5-10.3) were significantly associated with unattempted CVC, whereas coagulopathy was not (AOR 0.6; 95% CI, 0.2-1.8). Obesity was not significantly associated with unattempted CVC, either thoracic in location or at any site.Septic patients eligible for EGDT with relative normotension and those with moderate thrombocytopenia were less likely to undergo attempted CVC at any site. Those with coagulopathy were also less likely to undergo attempted thoracic central line placement. Knowledge of the decision-making calculus at play for physicians considering central venous catheterization in this population can help inform physician education and performance improvement programs.

Project description:Dynamic tests of fluid responsiveness have been developed and investigated in clinical trials of goal-directed therapy. The impact of this approach on clinically relevant outcomes is unknown. We performed a systematic review and meta-analysis to evaluate whether fluid therapy guided by dynamic assessment of fluid responsiveness compared with standard care improves clinically relevant outcomes in adults admitted to the ICU.Randomized controlled trials from MEDLINE, EMBASE, CENTRAL, clinicaltrials.gov, and the International Clinical Trials Registry Platform from inception to December 2016, conference proceedings, and reference lists of relevant articles.Two reviewers independently identified randomized controlled trials comparing dynamic assessment of fluid responsiveness with standard care for acute volume resuscitation in adults admitted to the ICU.Two reviewers independently abstracted trial-level data including population characteristics, interventions, clinical outcomes, and source of funding. Our primary outcome was mortality at longest duration of follow-up. Our secondary outcomes were ICU and hospital length of stay, duration of mechanical ventilation, and frequency of renal complications. The internal validity of trials was assessed in duplicate using the Cochrane Collaboration's Risk of Bias tool.We included 13 trials enrolling 1,652 patients. Methods used to assess fluid responsiveness included stroke volume variation (nine trials), pulse pressure variation (one trial), and stroke volume change with passive leg raise/fluid challenge (three trials). In 12 trials reporting mortality, the risk ratio for death associated with dynamic assessment of fluid responsiveness was 0.59 (95% CI, 0.42-0.83; I = 0%; n = 1,586). The absolute risk reduction in mortality associated with dynamic assessment of fluid responsiveness was -2.9% (95% CI, -5.6% to -0.2%). Dynamic assessment of fluid responsiveness was associated with reduced duration of ICU length of stay (weighted mean difference, -1.16 d [95% CI, -1.97 to -0.36]; I = 74%; n = 394, six trials) and mechanical ventilation (weighted mean difference, -2.98 hr [95% CI, -5.08 to -0.89]; I = 34%; n = 334, five trials). Three trials were adjudicated at unclear risk of bias; the remaining trials were at high risk of bias.In adult patients admitted to intensive care who required acute volume resuscitation, goal-directed therapy guided by assessment of fluid responsiveness appears to be associated with reduced mortality, ICU length of stay, and duration of mechanical ventilation. High-quality clinical trials in both medical and surgical ICU populations are warranted to inform routine care.