EBQ:ProMISe Trial - Revision history

Ostermayer: /* Funding */

2016-02-26T23:25:39Z

Funding

← Older revision		Revision as of 23:25, 26 February 2016
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	==Funding==		==Funding==
	The NIHR Health Technology Assessment (HTA) Programme (07/37/47) is supported the central coordination of the trial through the ICNARC CTU, and the local site start up costs. This includes dedicated local research nurses and the economic evaluation.		The NIHR Health Technology Assessment (HTA) Programme (07/37/47) is supported the central coordination of the trial through the ICNARC CTU, and the local site start up costs. This includes dedicated local research nurses and the economic evaluation.

			==See Also==
			*[[Sepsis]]

	==References==		==References==

Neil.m.young at 20:29, 26 February 2016

2016-02-26T20:29:08Z

← Older revision		Revision as of 20:29, 26 February 2016
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	The NIHR Health Technology Assessment (HTA) Programme (07/37/47) is supported the central coordination of the trial through the ICNARC CTU, and the local site start up costs. This includes dedicated local research nurses and the economic evaluation.		The NIHR Health Technology Assessment (HTA) Programme (07/37/47) is supported the central coordination of the trial through the ICNARC CTU, and the local site start up costs. This includes dedicated local research nurses and the economic evaluation.

	==~~Sources~~==		==References==
	<references/>		<references/>

	[[Category:EBQ]][[Category:Critical Care]]		[[Category:EBQ]][[Category:Critical Care]]

Ostermayer at 22:08, 17 June 2015

2015-06-17T22:08:11Z

← Older revision		Revision as of 22:08, 17 June 2015
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	\| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1500896		\| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1500896
	\| pdfurl=		\| pdfurl=
	\| status=~~Under Review~~		\| status=Complete
	}}		}}
	==Clinical Question==		==Clinical Question==

Ostermayer at 21:35, 17 June 2015

2015-06-17T21:35:19Z

← Older revision		Revision as of 21:35, 17 June 2015
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	<references/>		<references/>

	[[Category:EBQ]]		[[Category:EBQ]][[Category:Critical Care]]

Ostermayer at 05:38, 16 May 2015

2015-05-16T05:38:59Z

← Older revision		Revision as of 05:38, 16 May 2015
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	\| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1500896		\| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1500896
	\| pdfurl=		\| pdfurl=
			\| status=Under Review
	}}		}}
	==Clinical Question==		==Clinical Question==

Ostermayer: /* Conclusion */

2015-05-16T05:38:18Z

Conclusion

← Older revision		Revision as of 05:38, 16 May 2015
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	==Conclusion==		==Conclusion==
	Using EGDT did not lead to an improved outcomes.		Using EGDT did not lead to an improved outcomes.

	==Major Points==		==Major Points==

Neil.m.young at 18:21, 8 May 2015

2015-05-08T18:21:21Z

← Older revision		Revision as of 18:21, 8 May 2015
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	**2.6 vs 2.2 (p=0.005)		**2.6 vs 2.2 (p=0.005)

	===Findings with Non Significant Differences====		====Findings with Non Significant Differences====
	*SOFA score at 72hrs		*SOFA score at 72hrs
	*Receipt of advanced respiratory, or renal support and when it started		*Receipt of advanced respiratory, or renal support and when it started
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	*All-cause mortality at 28 days, hospital discharge, and 1yr		*All-cause mortality at 28 days, hospital discharge, and 1yr
	*Health related quality of life, resource use, and cost at 90d and 1yr		*Health related quality of life, resource use, and cost at 90d and 1yr

	==Criticisms & Further Discussion==		==Criticisms & Further Discussion==
	*There was a trend towards being more cost effective with usual-care ($17,647 vs $16,239, p=0.26).		*There was a trend towards being more cost effective with usual-care ($17,647 vs $16,239, p=0.26).

Neil.m.young at 18:21, 8 May 2015

2015-05-08T18:21:02Z

← Older revision		Revision as of 18:21, 8 May 2015
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	\| title= Trial of Early, Goal-Directed Resuscitation for Septic Shock		\| title= Trial of Early, Goal-Directed Resuscitation for Septic Shock
	\| abbreviation= ProMISe Trial		\| abbreviation= ProMISe Trial
			\| expansion= Protocolised Management In Sepsis
	\| published= April 2, 2015		\| published= April 2, 2015
	\| author= Mouncey PR, Osborn TM, Power GS, et al		\| author= Mouncey PR, Osborn TM, Power GS, et al
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	==Conclusion==		==Conclusion==
	Using EGDT did not lead to an improved ~~outcome~~		Using EGDT did not lead to an improved outcomes.

	==Major Points==		==Major Points==
			*Mortality was no different at 90-days 29.5% vs 29.2%
			*Slight increase is SOFA score at the first 6 hours in the EGDT group (assessment of organ dysfuction)
			*Slight increase in length of stay in the ICU

	==Study Design==		==Study Design==
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	===Exclusion Criteria===		===Exclusion Criteria===
	*~~CVA~~		*Age <18yrs
	*~~ACS~~		*Known pregnancy
	*~~Cardiac dysrhythmia~~		*Primary diagnosis of:
	*Acute pulmonary edema		**CVA, Acute pulmonary edema, Status asthmaticus, Major cardiac arrhythmia, Seizure, Drug overdose, Burn or trauma
	*GI bleed		*GI bleeding
	*Seizure		*Known AIDS
	*Drug overdose		*Requirement for immediate surgery
	*Burn or trauma		*DNR or advanced directives restricting the protocol
	*~~Immediate surgery needed~~		*Contraindication to central line or blood transfusion
	*~~CD4 count <50~~		*Transfer
	*~~Advance directive that restricts either~~ protocol
	*Contraindication to ~~interventions including refusal of~~ blood ~~transfusions~~
	*Pregnant
	*Transfer ~~patient~~

	==Interventions==		==Interventions==
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	*Reassess		*Reassess
	===Group 2 – Usual Care (n=620)===		===Group 2 – Usual Care (n=620)===
	*~~Airway/Breathing~~		*Typical care provided at clinician's discretion
	*~~2 large bore IVs (or central line if not achieved)~~		*Restricted usag of ScvO2 monitoring
	*Sedation, analgesia, and/or paralysis
	*Resuscitate with 2L IVF
	*IVF and vasopressors per MAPs
	*Reassess

	==Outcomes==		==Outcomes==


	===Primary Outcome===		===Primary Outcome===
			*All-cause mortality at 90 days
			**29.5% vs 29.2% (p=0.90)

	===Secondary Outcomes===		===Secondary Outcomes===
			====Findings with Significant Differences====
			*SOFA score at 6hr
			**6.4 vs 5.6 (p<0.001)
			*Receipt of advanced cardiac support
			**37.0 vs 30.9 (p=0.026)
			*LOS in ICU
			**2.6 vs 2.2 (p=0.005)

	===~~Subgroup analysis~~===		===Findings with Non Significant Differences====
			*SOFA score at 72hrs
			*Receipt of advanced respiratory, or renal support and when it started
			*Days free of the above advance support
			*LOS in ED and hospital
			*Duration of survival
			*All-cause mortality at 28 days, hospital discharge, and 1yr
			*Health related quality of life, resource use, and cost at 90d and 1yr



	==Criticisms & Further Discussion==		==Criticisms & Further Discussion==
			*There was a trend towards being more cost effective with usual-care ($17,647 vs $16,239, p=0.26).
			*The usual-care group still had a large portion of arterial lines and central lines. If we eliminate ScvO2 monitoring, the protocol becomes essentially guidelines for care.
			*Expected mortality in this group 40% while actual mortality was 29%. This matches closely with the 30.5% found in the Rivers 2001 EGDT Trial. This is the first time these numbers have been replicated as the US ProCESS Trial had a mortality rate of 18.9% at 60 days (compared to 30-46% as expected) and the Australia/New Zealand ARISE Trial had mortality 18.8% at 90 days (compared to 38% anticipated).

	==External Links==		==External Links==
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	==Funding==		==Funding==
			The NIHR Health Technology Assessment (HTA) Programme (07/37/47) is supported the central coordination of the trial through the ICNARC CTU, and the local site start up costs. This includes dedicated local research nurses and the economic evaluation.

	==Sources==		==Sources==

Neil.m.young at 17:07, 8 May 2015

2015-05-08T17:07:04Z

← Older revision		Revision as of 17:07, 8 May 2015
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	==Population==		==Population==
	56 hospitals in the UK		56 hospitals in the UK from Feb 2, 2011 to Jul 24, 2014 (29% teaching hospitals)
	===Patient Demographics===		===Patient Demographics===
			*Highlights
			**Only significant difference was age (66.4 vs 64.3)
			**~58% male
			**~55% had refractory hypotension
			**~64% had hyperlactatemia

	===Inclusion Criteria===		===Inclusion Criteria===
	*≥18 years of age		*≥18 years of age

Neil.m.young at 17:02, 8 May 2015

2015-05-08T17:02:54Z

← Older revision		Revision as of 17:02, 8 May 2015
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	==Study Design==		==Study Design==
			Pragmatic, open, multicenter, parallel-group, randomized, controlled trial

	==Population==		==Population==
	56 hospitals in the UK		56 hospitals in the UK