Web site designed and maintained by Chris Cairns  © SICS EBM Group 2004                                  

The effects of 6 and 24 hour sepsis care bundles on hospital mortality rates in patients with severe sepsis / septic shock

Citation/s: Gao F, Melody T et al. The impact of compliance with 6-hour and 24-hour sepsis bundles on hospital mortality in patients with severe sepsis: a prospective observational study. Critical Care 2005, 9:R764-R770 (DOI 10.1186/cc3909)

 
Lead author's name and email: Fang Gao. f.g.smith@bham.ac.uk

Three-part Clinical Question:                                                                                  

Patients: 101 adults in A&E or on medical or surgical wards with severe sepsis or septic shock                                                                                                           

Interventions: Compliance with 6 and 24 hour sepsis bundles                                    

Outcomes: hospital mortality

Search Terms: Sepsis, bundles, therapy, outcome

The Study: Cohort Study.

The Study Patients: Patients aged 18 or over (median age 69, M/F 53/48) who were admitted to A&E (n=11) or medical or surgical wards (n=90) with severe sepsis or septic shock as defined by the International Sepsis Definitions Conference (2001), recruited from two acute NHS trust teaching hospitals in England over a 5 month period.
 

Exposure of Interest: 6 and 24 hour sepsis bundles. Bundles differed from the SSC guidelines: target haemoglobin of 7-9g/dl instead of haematocrit ≥30% and used remaining hypotension after fluid resuscitation as threshold for inotropes instead of central venous saturation. Patients were considered to have complied with the bundles only if all aspects had been achieved. (see http://www.biomedcentral.com/content/supplementary/cc3909-S1.doc for reference)
 

The Outcome: Exposure of interest: Compliance with bundles. Outcome: Hospital mortality.
Patients in each group were similar in terms of age, sex, septic source, medical : surgical ratio, MEWS score and need for 24hr bundle. The exposures and outcomes were objective but not measured blind. Follow-up was long enough; follow-up was complete.  

The Evidence:

EBM Comments:

1.      Do the methods allow testing of the hypothesis?
This is a pilot study with small numbers of patients and is subject to observer bias. The bundles used differ from the SSC bundles and therefore are not accurately testing the SSC bundles in common clinical use. The patient characteristics were not fully described in terms of co-morbidity, severity of sepsis etc.

2.      Do the statistical tests correctly test the results to allow differentiation of statistically significant results?
The study is not adequately powered to differentiate statistically significant results in the 24 hour bundle group, although the results in the 6 hour group are statistically significant.

3.      Are the conclusions valid in light of the results?
The conclusion that compliance with evidence based guidelines significantly reduces mortality in this case cannot be drawn from this data alone. This is because the sample size is too small, the results are not all statistically significant and the guidelines used in this paper deviate from the accepted SSC sepsis bundles. The conclusion that there is inadequate ward care in critically ill patients is valid.

4.      Did any results get omitted and why?
Only the patients who were admitted to a critical care unit were analysed for the 24 hour sepsis bundle data. It is not clear what happened to the patients who were not admitted to a CCU. Results relating to central venous pressures and CV oxygen saturation were not included in the bundles due to resource limitations This has implications for the institution of some of the other bundles (e.g. decision to start vasopressors)

5.      Did they suggest areas of further research?
Yes. Larger scale studies on compliance.

6.      Did they make recommendations based on the results and were they appropriate?
Recommendations that further studies are needed is appropriate.

7.       Is the study relevant to my clinical practice?
Yes. Surviving sepsis bundles are widely employed in ICUs throughout the country. The importance of meeting 6 hour bundle targets emphasises the need for education of "front line" doctors (A&E staff, medical and surgical receiving teams) in the recognition and instigation of management of severe sepsis before transfer to ICU / HDU.

8.      What level of evidence does this study represent? 2^-

9.      What grade of recommendation can I make based on this study alone? None.

10.  What grade of recommendation can I make when this study is considered along with other available evidence? D

11.   Should I change my current practice because of these results?
Adherence to sepsis bundles as part of the Surviving Sepsis Campaign should be part of daily ICU care. This paper highlights the importance of meeting early targets suggesting that these bundles should not just be for the ICU doctor, and that education is required for medical and nursing staff meeting these patients at an early stage.

12.  Should I audit my current practice because of these results?
Yes. Ideally as part of a standardised auditing tool (such as that proposed by the surviving sepsis group)

Appraised by: Dr. Rachel Kearns (SHO GRI / SRI ??); 02 October 2006
Email: rkearns79@hotmail.com

Kill or update By: October 2011

Reviewed & Edited by: CC and MH

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. 2007. Kearns R. Gao F, Melody T et al. The impact of compliance with 6-hour and 24-hour sepsis bundles on hospital mortality in patients with severe sepsis: a prospective observational study. Critical Care 2005, 9:R764-R770 (DOI 10.1186/cc3909)

Printer friendly view

 ©SICS EBM 2007