Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510835
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2007-07-18
Brief Title:
Protocolized Care for Early Septic Shock
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Protocolized Care for Early Septic Shock
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProCESS
Brief Summary:
The ProCESS study is large 5-year multicenter study of alternative resuscitation strategies for septic shock The study hypothesizes that there are golden hours in the initial management of septic shock where prompt rigorous standardized care can improve clinical outcomes
Detailed Description:
Septic shock is a condition of acute organ dysfunction due to severe infection with a mortality of up to 50 Current efforts to improve care are limited by little practical evidence regarding the interventions in and timing of sepsis therapies ProCESS is a prospective randomized three-arm parallel-group trial of alternative resuscitation strategies for early septic shock The study objective is to improve the management of septic shock by exploring the clinical biological and economic aspects of alternative resuscitation strategies This will be done by comparing two alternative resuscitation strategies to usual care in subjects with septic shock
Comparisons
1 Early Goal Directed Therapy EGDT - The subjects blood pressure and blood oxygen levels will be monitored via the insertion of a central venous catheter CVC The study team will use this information to give fluid blood and heart medications in a structured fashion The central venous catheter to be used in this plan is FDA approved and routinely used in hospitals
2 Protocolized Standard Care PSC - The subjects blood pressure and blood oxygen levels will be monitored with standard equipment without the CVC The study team will use this information to prescribe fluid and heart medications in a structured fashion CVCs will only be used when standard IVs cannot give the proper amount of fluids and medicines Blood transfusions will be given according to currently recommended guidelines
3 Usual Care UC - Subjects will be treated according to their attending physicians standard treatment plan and without any influence from the study team
The primary hypotheses to be tested sequentially are that protocolized resuscitation EGDT and PSC results in lower hospital mortality than usual care and Early Goal Directed Therapy results in lower hospital mortality than Protocolized Standard Care These hypotheses will be tested on all enrolled subjects
The study is powered to find an absolute mortality reduction ARR of 6-7 Based on the control arm mortality rate we originally estimated a sample size of 1950 During the trial the ProCESS Coordinating Center monitored the overall mortality rate and appreciated that it was markedly lower than originally projected Therefore following a series of new calculations in February 2013 the trial was re-sized to 1350 patients 450 patients per arm The new size preserves the same power to find the same ARR The resizing was fully blinded and approved by the NIH
Comparisons
1 Early Goal Directed Therapy EGDT - The subjects blood pressure and blood oxygen levels will be monitored via the insertion of a central venous catheter CVC The study team will use this information to give fluid blood and heart medications in a structured fashion The central venous catheter to be used in this plan is FDA approved and routinely used in hospitals
2 Protocolized Standard Care PSC - The subjects blood pressure and blood oxygen levels will be monitored with standard equipment without the CVC The study team will use this information to prescribe fluid and heart medications in a structured fashion CVCs will only be used when standard IVs cannot give the proper amount of fluids and medicines Blood transfusions will be given according to currently recommended guidelines
3 Usual Care UC - Subjects will be treated according to their attending physicians standard treatment plan and without any influence from the study team
The primary hypotheses to be tested sequentially are that protocolized resuscitation EGDT and PSC results in lower hospital mortality than usual care and Early Goal Directed Therapy results in lower hospital mortality than Protocolized Standard Care These hypotheses will be tested on all enrolled subjects
The study is powered to find an absolute mortality reduction ARR of 6-7 Based on the control arm mortality rate we originally estimated a sample size of 1950 During the trial the ProCESS Coordinating Center monitored the overall mortality rate and appreciated that it was markedly lower than originally projected Therefore following a series of new calculations in February 2013 the trial was re-sized to 1350 patients 450 patients per arm The new size preserves the same power to find the same ARR The resizing was fully blinded and approved by the NIH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None