Protocolized Care for Early Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock; Severe Sepsis; Sepsis
• Interventions: Procedure: Protocolized Standard Care (PSC); Procedure: Early Goal Directed Therapy (EGDT); Procedure: Usual Care (UC)

• Registration Number: NCT00510835
• Lead Sponsor: University of Pittsburgh

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 physician's 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Study Start: 2008-03
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2016-12
• Results First Submitted: 2016-12-01
• Results First Submitted QC: 2016-12-01
• Last Update Submitted: 2016-12-01
• Results First Posted: 2017-01-26
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1351

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Protocolized Standard Care (PSC)	Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.
1	Early Goal Directed Therapy (EGDT)	Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.
3	Usual Care (UC)	Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.

Primary Outcome Measures

Name	Time	Method
Hospital Mortality	prior to discharge or 60 days, whichever comes first	The primary study outcome is hospital mortality (defined as the number of deaths prior to discharge or 60 days, whichever comes first). The secondary outcomes are duration of survival (90 day and 1 year) and clinical evidence of organ dysfunction.

Secondary Outcome Measures

Name	Time	Method
Resource Use and Costs of Alternative Resuscitation Strategies	at discharge or 60 days, whichever comes first
Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.	study hour 0, 6, 24 & 72

Trial Locations

Locations (31)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

UPMC Shadyside Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

LA County & USC Medical Center; 🇺🇸 Los Angeles, California, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Louisiana State University Health Sciences Center/Shreveport; 🇺🇸 Shreveport, Louisiana, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Maricopa Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Methodist Research Institute; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland/Baltimore; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

State University of New York - Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Summa Health System; 🇺🇸 Akron, Ohio, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University Medical Center Brackenridge; 🇺🇸 Austin, Texas, United States

Intermountain Medical Center; 🇺🇸 Salt Lake City, Utah, United States

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States

Penn State Hershey College of Medicine; Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States