EGDT SEPSIS PDF
In the Rivers study, septic shock was regarded as an emergency department study and EGDT was applied immediately after ED. Revised and reviewed 14 February OVERVIEW. Early Goal Directed Therapy (EGDT) definition. Within 6 hours of presentation to the. In the event of persistent hypotension despite fluid resuscitation (septic shock) or lactate help clinicians at the bedside to resuscitate patients in septic shock.
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National Guideline Centre UK. Recognition, Assessment and Early Management. The management of sepsis consists of a bundle of actions to be taken as soon as possible after diagnosis.
Early goal-directed therapy EGDT is a protocoled approach to the management of severe sepsis during the first six hours after diagnosis. The treatment bundle includes antimicrobials, fluid resuscitation, inotropic agents or vasopressors, and continuous monitoring of haemodynamic parameters to ensure an adequate blood flow and tissue oxygenation. While early trials have shown a significant egdg benefit for patients receiving EGDT, more recent studies could not identify any difference eget EGDT and what is considered to be standard therapy.
The guideline scope did not sepis review of EGDT. The guideline focus is on early recognition and initial management and treatment and not appropriate ebdt monitoring such as that used in EGDT. The GDG were aware however of recent trials in emergency departments and that routine care in the trials was an indication of high standard routine care.
Given the lack of good quality trial evidence for individual interventions in very early sepsis, the GDG were interested in the information available from the EGDT trials on standard care. View in own window. A recent systematic review 14 assessing the randomised clinical trial evidence for EGDT in the resuscitation of patients presenting to the ED with septic shock, egxt identified and included in this evidence report.
The systematic review aimed to address the primary question of whether EGDT, when compared with other resuscitation strategies, was associated with a survival benefit. The review by Angus et al included 11 studies, of which five, enrolled patients presenting to the ED with septic shock and were suitable for assessment of the primary objective.
These studies also matched our protocol criteria and were included in this evidence report. The systematic review is summarised in Table Summary of systematic review included in this review below and further details can be found in Appendix H.
Summary of study and baseline characteristics of included trials of EGDT in septic shock below provides a summary of the key included trial and baseline population characteristics, and Table provides a summary of the EGDT protocol and outcomes in each of these studies. Further details of the included studies, including study design, settings, inclusion criteria, study outcome results, and any subgroup analyses carried out in the individual studies, is given in Table Summary of study and baseline characteristics of included trials of EGDT in septic shock.
Table summarises particular therapies fluids, vasopressor, dobutamine, blood transfusion and time to first antimicrobial delivered during the six hour resuscitation period in each study. A more detailed breakdown of these and other therapies delivered to each study arm during the ProMISe, the UK study, has been given in Table and Table Table details authors’ description of assessments and procedures carried out pre-randomisation in each study inclusion criteria to the trial.
Early management of sepsis with emphasis on early goal directed therapy: AME evidence series
Interventions delivered between randomisation and 6 hours post-randomisation. Interventions delivered at baseline. Interventions delivered during the hour intervention period. Descriptions of pre-randomisation assessments and procedures for all patients, and usual or standard care arm included trials. One economic evaluation was identified with the relevant comparison and has been included in this review. See also the economic article selection flow chart in Appendix F.
Low and moderate quality evidence from one systematic review found no survival benefit of EGDT over usual care. Turn recording back on. National Center for Biotechnology InformationU.
Introduction The management of sepsis consists of a bundle of actions to be taken as soon as possible after diagnosis. What is the clinical and cost effectiveness of implementing early goal-directed therapy Sepdis for people with sepsis? For full details see review protocol in Appendix C.
Early Goal Directed Therapy in Septic Shock
Table PICO characteristics of review question View in own window Population People at risk of developing or diagnosed with severe sepsis. Strata by severity disease: Clinical evidence A recent systematic review 14 assessing the randomised clinical trial evidence for EGDT in the resuscitation of patients presenting to the ED with septic shock, was identified and included in this evidence report.
Table Summary of systematic review included in this review. Table Further details of studies included in review. Table Interventions delivered between randomisation and 6 hours post-randomisation. Table Descriptions of pre-randomisation assessments and procedures for all wepsis, and usual or standard care arm included trials. Table Clinical evidence summary: Economic evidence Published literature One economic evaluation was identified with the relevant comparison and has been included in this review.
Table Economic evidence profile: EGDT versus usual care. Evidence statements Clinical Low and moderate quality evidence from one systematic review found no survival benefit of EGDT over usual care. Relative values of different outcomes The GDG considered all-cause mortality at 28 days health-related quality of life, and rate of admission to ICU to be critical outcomes. Length of ICU stay, length of hospital stay, number of organs supported and time to reversal of shock, and adverse events were considered important outcomes.
Trade-off between clinical benefits and harms The included study was a relevant and recent systematic review. From this review we included five open-label RCTs in adult patients with septic shock, which reported the above outcomes. This study also carried the highest weighting in our analysis due to its large sample size. For the overall primary mortality outcome, analysis included all depsis RCTs.
There were many suggestions given by the GDG for this difference, as well as discussion of shortcomings of this trial. For day mortality there was also no difference between EGDT and control arms. The GDG also noted that, an explanation for the similarity between groups in ICU length of stay could be attributed to the fact that by nature of all patients being participants in a large trial, both groups would have continued to receive a high seosis of care.
The GDG also suggested that the standard of current clinical practice sfpsis evolved to be higher in more recent years, and this could be an explanation for the finding of no difference in length of stay, ebdt well as no overall significant benefit from EGDT. This is a within trial economic evaluation based on the ProMISe trial. The paper was rated as directly applicable with potentially serious limitations.
Some of the limitations include that the time horizon was 90 days, and also no adverse events were included, also some of the methodology is unclear. Resources are likely to be required in setting up a formal EGDT resuscitation protocol, such as training costs — training staff to follow and implement the protocol and the opportunity cost of staff time that would be involved in this.
This might depend on setting, for example if in ED then equipment might also need to be upgraded such as monitors for oxygen saturation monitoring. Whether this more expensive intervention is cost effective will depend on the benefit it provides, and the clinical review identified that all except one trial showed no difference in mortality between EGDT and usual care.
The GDG agreed that as the standard of care is much higher in recent times, EGDT or a formal sepsiz protocol in general would provide no benefit in clinical practice, as the evidence has confirmed.
It was noted that usual care in a trial is likely to be of a egdy standard than usual care in practice, and therefore setting a high standard of usual care for suspected sepsis or sepsis patients is the overall aim. The GDG did not make a recommendation because no clinical benefit was identified, and making a do not use recommendation might be misinterpreted, so they considered that continuation of current practice was the best way forward.
Quality of evidence The included systematic review was of high quality and directly relevant to our review question. The evidence from the included RCTs was generally of moderate to low quality. This was due to risk of bias as all outcomes were downgraded by one increment due to lack of blinding.
The lack of blinding was inevitable, since it would be almost impossible to study intensive investigator-blinded ScvO 2 -guided resuscitation. While lack of blinding and sgdt of ehdt could have influenced outcomes, the meta-analyses showed no difference between EGDT and control groups for most outcomes. Furthermore, the three multicentre trials were methodologically harmonised and well-conducted.
They were precise; highly powered to detect differences; the groups were matched at baseline; data were analysed by the intention-to-treat principle; and there was a very good follow-up rate for the primary depsis. They considered that the standard of routine care in the trials was very high and they were concerned that a recommendation saying not to carry out EGDT would be misinterpreted. The GDG were also aware that the individual patient data from EGDT studies is currently being analysed and the findings from this may inform whether some patients would benefit from this approach.
In order for the GDG to understand how usual care was defined in the trials, and to identify ways in which the current standard of usual care in the UK could potentially be improved, additional data from the UK ProMISe study supplementary protocols and appendices, were presented and discussed.
A detailed description of assessments, procedures, and interventions administered to patients prior to randomisation, at baseline, and during hours in the trial were considered. The GDG noted the range of baseline blood lactate concentration, ranging from 1.
Also of interest was the timing of CVC insertion to answer the earlier question as the guideline scope had included this as a question. The ProMISe study investigators, following personal communication, provided data on this, with 21 patients 3.
These patients were included within the and patients in EGDT and usual care groups, respectively, who had a CVC in place during hours of the trial.
Thus it is evident that a minimum number of patients required central venous access before more intensive treatment and monitoring as carried out in the trial. Clinical evidence Economic evidence Evidence statements Recommendations and link to evidence.
Duration of hospital stay Duration of critical care stay Number of organs supported for example, SOFA score Time to reversal of shock Adverse events long term disability; short-term heart failure.
Relative values of different outcomes.
Early goal-directed therapy
The GDG considered all-cause mortality at 28 days health-related quality of life, and rate of admission to ICU to be critical outcomes. Trade-off between sgdt benefits and harms. The included study was a relevant and recent systematic review. The included systematic review was of high quality and directly relevant to our review question.