EBQ:ProCESS Trial - Revision history

Hvertelney: /* Major Points */

2019-07-24T03:10:26Z

Major Points

← Older revision		Revision as of 03:10, 24 July 2019
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	}}		}}
	==Clinical Question==		==Clinical Question==
	'''In patients with severe sepsis in the Emergency Department ~~dose~~ protocol-based resuscitation improve outcomes'''		'''In patients with severe sepsis in the Emergency Department does protocol-based resuscitation improve outcomes'''

	==Conclusion==		==Conclusion==
	'''No mortality or morbidity benefit was found with protocol-based resuscitation compared to bedside care in patients with severe sepsis.'''		'''No mortality or morbidity benefit was found with protocol-based resuscitation compared to bedside care in patients with severe sepsis.'''

	==Major Points==		==Major Points==
	*This multicenter randomized trial assigned ~~patients~~ 1341 patients to protocol EGDT (Early Goal Directed Therapy), protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions or ''usual care'' which was not standardized. The data was analyzed with intention to treat to determine in protocolized treatment of sepsis had a mortality benefit as was shown in the original Rivers Trial. No significant 60 or 90 day mortality benefit was found to the protocol therapy and greater hospital resources such as ICU admissions were found in the protocol based groups.		*This multicenter randomized trial assigned 1341 patients to protocol EGDT (Early Goal Directed Therapy), protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions or ''usual care'' which was not standardized. The data was analyzed with intention to treat to determine in protocolized treatment of sepsis had a mortality benefit as was shown in the original Rivers Trial. No significant 60 or 90 day mortality benefit was found to the protocol therapy and greater hospital resources such as ICU admissions were found in the protocol based groups.

	*There as an increased use of vasopressors, dobutamine, and blood transfusions in the protocol EGDT group. There was more volume given within 6 hours in the protocol-based standard therapy group. The EGDT group received more vasopressors and dobutamine, and blood transfusions than the other two groups.		*There as an increased use of vasopressors, dobutamine, and blood transfusions in the protocol EGDT group. There was more volume given within 6 hours in the protocol-based standard therapy group. The EGDT group received more vasopressors and dobutamine, and blood transfusions than the other two groups.
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	{{Quote\|text=One important contribution of the ProCESS trial is the evidence it provides regarding the ongoing role of early recognition of and antibiotic treatment for sepsis in improving survival...The ProCESS trial identifies early recognition of sepsis, early administration of antibiotics, early adequate volume resuscitation, and clinical assessment of the adequacy of circulation as the elements we should focus on to save lives. The publication of the ProCESS trial launches the era of early recognition and treatment in the management of sepsis.\|sign=Craig M. Lilly, M.D\|source=Editorial: The ProCESS Trial — A New Era of Sepsis Management<ref>www.nejm.org/doi/full/10.1056/NEJMe1402564</ref> }}		{{Quote\|text=One important contribution of the ProCESS trial is the evidence it provides regarding the ongoing role of early recognition of and antibiotic treatment for sepsis in improving survival...The ProCESS trial identifies early recognition of sepsis, early administration of antibiotics, early adequate volume resuscitation, and clinical assessment of the adequacy of circulation as the elements we should focus on to save lives. The publication of the ProCESS trial launches the era of early recognition and treatment in the management of sepsis.\|sign=Craig M. Lilly, M.D\|source=Editorial: The ProCESS Trial — A New Era of Sepsis Management<ref>www.nejm.org/doi/full/10.1056/NEJMe1402564</ref> }}


	==Study Design==		==Study Design==

Ostermayer: /* Funding */

2014-10-13T16:06:08Z

Funding

← Older revision		Revision as of 16:06, 13 October 2014
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	*Funded by the National Institute of General Medical Sciences		*Funded by the National Institute of General Medical Sciences
	*ClinicalTrials.gov: [http://www.clinicaltrials.gov/ct2/show/NCT00510835?term=NCT00510835&rank=1 NCT00510835]		*ClinicalTrials.gov: [http://www.clinicaltrials.gov/ct2/show/NCT00510835?term=NCT00510835&rank=1 NCT00510835]

			==See Also==
			*[[Sepsis]]
			*[[Initial Antibiotics in Sepsis (Main)]]
			*[[Sepsis (Peds)]]

	==Sources==		==Sources==

Ostermayer at 16:05, 13 October 2014

2014-10-13T16:05:03Z

← Older revision		Revision as of 16:05, 13 October 2014
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	**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines		**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines

	*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[ProCESS Trial]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>		*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[EBQ:ProCESS Trial\|ProCESS Trial]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>
	**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy '''does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation''' compared with controls.		**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy '''does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation''' compared with controls.
	**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.		**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.

Ostermayer at 16:04, 13 October 2014

2014-10-13T16:04:33Z

← Older revision		Revision as of 16:04, 13 October 2014
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	*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[ProCESS Trial]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>		*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[ProCESS Trial]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>
	**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls.		**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy '''does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation''' compared with controls.
	**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.		**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.
	**The results of the ProCESS and ARISE trials have not demonstrated any adverse outcomes in the groups that utilized CVP and ScvO2 as end points for resuscitation. Therefore, no harm exists in keeping the current SSC bundles intact until a thorough appraisal of all available data has been performed.		**The results of the '''ProCESS and ARISE trials have not demonstrated any adverse outcomes in the groups that utilized CVP and ScvO2 as end points for resuscitation'''. Therefore, no harm exists in keeping the current SSC bundles intact until a thorough appraisal of all available data has been performed.

	==Funding==		==Funding==

Ostermayer: /* Criticisms & Further Discussion */

2014-10-13T14:16:10Z

Criticisms & Further Discussion

← Older revision		Revision as of 14:16, 13 October 2014
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	**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines		**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines

	*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[ProCESS]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>		*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[ProCESS Trial]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>
	**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls.		**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls.
	**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.		**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.

Ostermayer at 14:11, 13 October 2014

2014-10-13T14:11:15Z

← Older revision		Revision as of 14:11, 13 October 2014
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	*A direct comparison cannot be made between the protocol EGDT group and the Rivers Trial because of greater severity of illness and persistence of shock and a small amount of non-compliance to the EGDT trial. Also usual care has advanced due to widespread sepsis education and the usual care in the Rivers Trial and the ProCESS trials are at different points of time in sepsis knowledge.		*A direct comparison cannot be made between the protocol EGDT group and the Rivers Trial because of greater severity of illness and persistence of shock and a small amount of non-compliance to the EGDT trial. Also usual care has advanced due to widespread sepsis education and the usual care in the Rivers Trial and the ProCESS trials are at different points of time in sepsis knowledge.

	*The Surviving Sepsis Campaign response to the ProCESS Trial:<ref>http://www.survivingsepsis.org/News/Pages/SSC-Responds-to-ProCESS-Trial.aspx [http://www.survivingsepsis.org/SiteCollectionDocuments/SSC-Responds-Process-Trial.pdf PDF]</ref>		*The Surviving Sepsis Campaign initial response to the ProCESS Trial:<ref>http://www.survivingsepsis.org/News/Pages/SSC-Responds-to-ProCESS-Trial.aspx [http://www.survivingsepsis.org/SiteCollectionDocuments/SSC-Responds-Process-Trial.pdf PDF]</ref>
	**Importance of early recognition of sepsis with source control and early antibiotics		**Importance of early recognition of sepsis with source control and early antibiotics
	**18% mortality rate in “usual care" is much better than the 46% seen in 2001 suggesting advances in sepsis care knowledge		**18% mortality rate in “usual care" is much better than the 46% seen in 2001 suggesting advances in sepsis care knowledge
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	**Repeat lactate testing not addressed in the ProCESS trial but other literate supports repeat testing		**Repeat lactate testing not addressed in the ProCESS trial but other literate supports repeat testing
	**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines		**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines

			*The Surviving Sepsis Campaign response to [[Arise Trial]] and [[ProCESS]] <ref>http://theddx.org/papers/SSCletterreversal.pdf</ref>
			**Required monitoring of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) via a central venous catheter (CVC) as part of an early resuscitation strategy does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls.
			**Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/L and/or persistent hypotension after initial fluid challenge who have received timely antibiotics is not supported by the available scientific evidence.
			**The results of the ProCESS and ARISE trials have not demonstrated any adverse outcomes in the groups that utilized CVP and ScvO2 as end points for resuscitation. Therefore, no harm exists in keeping the current SSC bundles intact until a thorough appraisal of all available data has been performed.

	==Funding==		==Funding==

Ostermayer at 18:23, 16 September 2014

2014-09-16T18:23:12Z

← Older revision		Revision as of 18:23, 16 September 2014
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	[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1401602/suppl_file/nejmoa1401602_appendix.pdf Supplemental Publication]		[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1401602/suppl_file/nejmoa1401602_appendix.pdf Supplemental Publication]

	[[Category:EBQ]]		[[Category:EBQ]][[Category:Featured]]

Ostermayer: /* Outcome */

2014-04-25T00:16:39Z

Outcome

← Older revision		Revision as of 00:16, 25 April 2014
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	;Vasopressor Use ''6-72hr''		;Vasopressor Use ''6-72hr''
	:EGDT:		:EGDT: 54.9%
	:Protocol based Standard Therapy:		:Protocol based Standard Therapy: vs. 52.2%
	:Usual Care:		:Usual Care: vs. 44.1%
	::p=		::p= 0.003

	;Dobutamine Use ''6-72hr''		;Dobutamine Use ''6-72hr''

Ostermayer: /* Criticisms & Further Discussion */

2014-04-11T00:09:54Z

Criticisms & Further Discussion

← Older revision		Revision as of 00:09, 11 April 2014
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	**Supports MAP target of 65mmHg		**Supports MAP target of 65mmHg
	**Repeat lactate testing not addressed in the ProCESS trial but other literate supports repeat testing		**Repeat lactate testing not addressed in the ProCESS trial but other literate supports repeat testing
	**Still encourages central lines ~~when necessary~~ since > 50% of the "usual care" patients received central lines		**Still encourages central lines as part of the 6hr bundle to check CVO<sub>2</sub> since > 50% of the "usual care" patients received central lines

	==Funding==		==Funding==

Ostermayer: /* Criticisms & Further Discussion */

2014-04-11T00:06:17Z

Criticisms & Further Discussion

← Older revision		Revision as of 00:06, 11 April 2014
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	*The Surviving Sepsis Campaign response to the ProCESS Trial:<ref>http://www.survivingsepsis.org/News/Pages/SSC-Responds-to-ProCESS-Trial.aspx [http://www.survivingsepsis.org/SiteCollectionDocuments/SSC-Responds-Process-Trial.pdf PDF]</ref>		*The Surviving Sepsis Campaign response to the ProCESS Trial:<ref>http://www.survivingsepsis.org/News/Pages/SSC-Responds-to-ProCESS-Trial.aspx [http://www.survivingsepsis.org/SiteCollectionDocuments/SSC-Responds-Process-Trial.pdf PDF]</ref>
	**Importance of early recognition of sepsis with source control and early antibiotics		**Importance of early recognition of sepsis with source control and early antibiotics
	**18% mortality rate in ~~“usual”~~ care is much better than the 46% seen in 2001 suggesting advances in sepsis care knowledge		**18% mortality rate in “usual care" is much better than the 46% seen in 2001 suggesting advances in sepsis care knowledge
	**ProCESS does not answer the question about using a protocol to manage patients with severe sepsis without septic shock		**ProCESS does not answer the question about using a protocol to manage patients with severe sepsis without septic shock
	**Supports MAP target of 65mmHg		**Supports MAP target of 65mmHg
	**Repeat lactate testing not addressed in the ProCESS trial but other literate supports repeat testing		**Repeat lactate testing not addressed in the ProCESS trial but other literate supports repeat testing
	**Still encourages central lines when necessary since > 50% of the usual care received central lines		**Still encourages central lines when necessary since > 50% of the "usual care" patients received central lines

	==Funding==		==Funding==