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Volume 3 Supplement 1

ESICM LIVES 2015

IMPACT OF TRIALS ON CLINICAL PRACTICE: INTERVENTIONS IN SEPTIC SHOCK PATIENTS BETWEEN 2005 AND 2013

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Introduction

Evidence based medicine [EBM] at bedside, a key healthcare quality measure, refers to the compendium for delivering optimum clinical care by balancing benefit-harm-costs. EBM involves appraisal, interpretation and implementation with adoption of beneficial interventions and de-adoption of interventions with potential harm.

Our hypothesis from Niven et al [1] where the reversal of intervention effect was not associated with timely de-adoption, is that for a rapid change in clinical practice perceived cost [monetary or clinical harm] attributable to the intervention must be high.

Tight glucose control [TGC] and corticosteroids are examples of nonproprietary and recombinant Activated protein C [rt-APC] an example of proprietary intervention with reversal of effect between publications, from benefit to harm. All three interventions were part of the Surviving Sepsis Campaign [SSC] EBM [2].

Objectives

We explored the impact of reversal of intervention effect in septic shock trials on the adoption - de-adoption cycle of these three interventions; hypothesis being visible 'cost' influences EBM.

Methods

Guy's and St. Thomas' NHS Foundation Trust (London, England) is a 1,150-bed, University hospital with closed mixed medical and surgical ICUs and an early adopter of the SSC. Trained data collectors prospectively recorded all ICU admissions with severe sepsis/septic shock (SS) [2005 to 2013] into the SSC database. We report the adoption - de-adoption cycle of the interventions with effect reversal [rt-APC, corticosteroids, TGC] or unchanged (Antibiotics < 3hours; lactate measurement < 6 hours and lung protective ventilation [LPV]) over this period, relative to seminal publications for each intervention in septic shock patients. [2] As an on-going hospital approved audit since inception, informed consent was waived. Data analysis was performed using Stata v13.1 (StataCorp, LP).

Results

N = 1,150 septic shock admissions. Compliance with intervention effect unchanged [antibiotics, lactate measurement and LPV] was high [Figure 1a]. Publication of CORTICUS [3]trial reduced steroid use, whereas with the publication of PROWESS-SHOCK [4] study alongside drug withdrawal stopped rt-APC use [Figure 1b]. Between the publications of Leuven-2 [5] and NICE-SUGAR [6] studies, the population average glucose values by quarter increased gradually from 5.7 to 7.6mmol/L, over the study period. This was associated with reduction in hypoglycemia incidence [Figure 1c].

Figure 1
figure1

1a)No vs 1b) Reversal vs 1c) Blood Sugar.

Conclusions

This descriptive analysis supports our hypothesis. Further analysis will identify key drivers for 'timely' EBM beyond SSC bundle compliance.

References

  1. 1.

    Niven DJ, Rubenfield GD, Kramer AA, Stelfox HT: Effect of published scientific evidence on glycemic control in adult intensive care units. JAMA Int Med. 2015, 175 (5): 801-809.

  2. 2.

    Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, et al: Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013, 41 (2): 580-637.

  3. 3.

    Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, et al: Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008, 358 (2): 111-124.

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    Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, et al: Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012, 366 (22): 2055-2064.

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    Van Den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, et al: Intensive insulin therapy in the medical ICU. N Engl J Med. 2006, 354: 449-461.

  6. 6.

    The NICE-SUGAR Study Investigators. Hypoglycemia and Risk of Death in Critically Ill Patients. N Engl J Med. 2012, 367: 1108-1118.

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Author information

Correspondence to A Jones.

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Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0), which permits use, duplication, adaptation, distribution, and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Jones, A., Bond, A., Whiteley, C. et al. IMPACT OF TRIALS ON CLINICAL PRACTICE: INTERVENTIONS IN SEPTIC SHOCK PATIENTS BETWEEN 2005 AND 2013. ICMx 3, A430 (2015) doi:10.1186/2197-425X-3-S1-A430

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Keywords

  • Septic Shock
  • Septic Shock Patient
  • Survive Sepsis Campaign
  • Protective Ventilation
  • Lung Protective Ventilation