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Protocolized Care for Early Septic Shock (ProCESS)

This study is currently recruiting participants.
Verified March 2013 by University of Pittsburgh
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00510835
First received: July 18, 2007
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
Severe Sepsis
Septic Shock
 Procedure: Early Goal Directed Therapy (EGDT)
Procedure: Protocolized Standard Care (PSC)
Procedure: Usual Care (UC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocolized Care for Early Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Hospital mortality [ Time Frame: prior to discharge or 60 days, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in markers of inflammation, oxidative stress, cellular hypoxia and coagulation/thrombosis. [ Time Frame: study hour 0, 6, 24 & 72 ] [ Designated as safety issue: No ]
  • Resource use and costs of alternative resuscitation strategies [ Time Frame: at discharge or 60 days, whichever comes first ] [ Designated as safety issue: No ]

Estimated Enrollment: 1350
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
 Procedure: Early Goal Directed Therapy (EGDT)
Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements.
Experimental: 2
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.
 Procedure: Protocolized Standard Care (PSC)
Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status.
Active Comparator: 3
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.
 Procedure: Usual Care (UC)
Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • At least 18 years of age
  • Suspected infection

  • Two or more systemic inflammatory response syndrome (SIRS) criteria

    • Temperature </= 36˚ C or >/= 38˚C
    • Heart rate >/= 90 beats per minute
    • Mechanical ventilation for acute respiratory process or respiratory rate >/= 20 breaths per minute or PaC02 < 32 mmHg
    • WBC >/= 12,000/mm³ OR </= 4,000/mm³ OR > 10% bands
  • Refractory hypotension (a systolic blood pressure < 90 mm Hg despite an IV fluid challenge of at least 1,000 mLs over a 30 minute period) or evidence of hypoperfusion (a blood lactate concentration >/= 4 mmol/L)

Exclusion criteria:

  • Known pregnancy
  • Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, active gastrointestinal hemorrhage, seizure, drug overdose, burn or trauma
  • Requirement for immediate surgery
  • ANC < 500/mm³
  • CD4 < 50/mm³
  • Do-not-resuscitate status
  • Advanced directives restricting implementation of the protocol
  • Contraindication to central venous catheterization
  • Contradiction to blood transfusion (e.g., Jehovah's Witness)
  • Treating physician deems aggressive care unsuitable
  • Participation in another interventional study
  • Transferred from another in-hospital setting
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510835

Contacts
Contact: Derek C. Angus, MD, MPH 412-647-8110 angusdc@upmc.edu
Contact: Tammy L. Eaton, MSN, FNP-BC 412-647-3689 eatontl@upmc.edu

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35249
Contact: Henry E. Wang, MD, MS     205-410-1267     hwang@uabmc.edu    
Principal Investigator: Henry E Wang, MD, MS            
Sub-Investigator: Mike Waldrum, MD            
United States, Arizona
Maricopa Medical Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Frank LoVecchio, DO, MPH     602-239-2358     Frank.LoVecchio@bannerhealth.com    
Contact: Mary Mulrow, RN, MN     602-344-5058     Mary_mulrow@medprodoctors.com    
Principal Investigator: Frank LoVecchio, DO, MPH            
Sub-Investigator: Richard Carlson, MD            
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Talmage Holmes, PhD, MPH     501-686-6993     tmholmes@waldenu.edu    
Contact: Erica A Sidea     501-526-7685     EASidea@uams.edu    
Principal Investigator: Talmage Holmes, PhD,MPH            
Sub-Investigator: Jonathan Palmer, MD            
United States, California
LA County & USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Stuart Swadron, MD     323-806-2937     swadron@usc.edu    
Contact: Jay Zhu     323-409-7180     jzhu@usc.edu    
Principal Investigator: Howard Belzberg, MD            
Sub-Investigator: Stuart Swadron, MD            
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94025
Contact: Ronald G. Pearl, MD, PhD     650-723-5024     rgp@stanford.edu    
Contact: Alison Pepper     650-721-1680     apepper@stanford.edu    
Principal Investigator: Ronald G. Pearl, MD, PhD            
Sub-Investigator: Matthew Strehlow, MD            
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Edward A. Panacek, MD, MPH     916-734-8569     eapanacek@ucdavis.edu    
Contact: Laura Beth Jones     916-734-7596     laurabeth.jones@ucdmc.ucdavis.edu    
Principal Investigator: Edward A. Panacek, MD, MPH            
Sub-Investigator: Timothy E. Albertson, MD, PhD            
United States, Connecticut
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Jonathan Fine, MD     203-855-3543     jonathan.fine@norwalkhealth.org    
Contact: Christine Belden, RN     203-852-3021     christine.belden@norwalkhealth.org    
Principal Investigator: Jonathan Fine, MD            
Sub-Investigator: Michael Carius, MD            
United States, District of Columbia
George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Lakhmir Chawla, MD     202-715-4570     lchawla@mfa.gwu.edu    
Contact: Christina Seneff     202-715-5257     cseneff@mfa.gwu.edu    
Principal Investigator: Lakhmir Chawla, MD            
Sub-Investigator: Munish Goyal, MD            
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: David P. Milzman, MD     202-210-8018     davidmilzman@me.com    
Contact: Ron Migues, MD     202- 877-0616     ron.m.migues@medstar.net    
Principal Investigator: David P. Milzman, MD            
Sub-Investigator: Munish Goyal, MD            
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33601
Contact: David Orban, MD     813-627-5931     David_Orban@teamhealth.com    
Contact: Jennifer Nilson     813-844-5477     jenniferanilson@tgh.org    
Principal Investigator: David Orban, MD            
Sub-Investigator: Richard Paula, MD            
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Hannah Watts, MD     773-276-4736     hwattsmd@gmail.com    
Contact: Kathleen Hesse, RN     708 684-3450     hessek4@gmail.com    
Principal Investigator: Hannah Watts, MD            
Sub-Investigator: Karis Tekwani, MD            
United States, Indiana
Methodist Research Institute Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Timothy Ellender, MD     317-962-5975     tellender@clarian.org    
Contact: Caroline Lynn, RN, BSN     317-962-2037     clynn@clarian.org    
Principal Investigator: Timothy Ellender, MD            
Sub-Investigator: Christopher Naum, MD            
United States, Louisiana
Louisiana State University Health Sciences Center/Shreveport Terminated
Shreveport, Louisiana, United States, 71103
United States, Maryland
University of Maryland/Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michael T McCurdy, MD     410-328-8141     drmccurdy@gmail.com    
Contact: Jennifer Davis     410-328-1473     jdavis2@medicine.umaryland.edu    
Principal Investigator: Haney Mallemat, MD            
Sub-Investigator: Michael T McCrudy, MD            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Filbin, MD     617-724-0348     mfilbin@partners.org    
Contact: Blair Parry, BA     617-724-4758     bparry@partners.org    
Principal Investigator: Michael Filbin, MD            
Sub-Investigator: Aaron Waxman, MD            
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Peter C. Hou, MD     617-732-5640     phou@partners.org    
Contact: Siddarth Parmar         sparmar@partners.org    
Principal Investigator: Peter C. Hou, MD            
Sub-Investigator: Anthony Massaro, MD            
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: James Miner, MD     612-873-4908     miner015@umn.edu    
Contact: Lila Steinberg     612-873-9528     lila.steinberg@hcmed.org    
Principal Investigator: James Miner, MD            
Sub-Investigator: Mark Sprenkle, MD            
United States, New York
State University of New York - Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Richard Sinert, DO     718-245-2973     nephron1@gmail.com    
Contact: Shweta Malhotra, MD     301-346-6220     malhotrashweta@aol.com    
Principal Investigator: Richard Sinert, DO            
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Todd Slesinger, MD     516-562-2426     tslesinger@yahoo.com    
Contact: Mary Frances Ward, RN, MS, ANP, CCRN     516-562-3710     mward@nshs.edu    
Principal Investigator: Andrew Sama, MD            
Sub-Investigator: Todd Slesinger, MD            
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Alexander Limkakeng, MD         alexander.limkakeng@duke.edu    
Contact: Debbie Freeman, BSN     919-684-5036     freem010@mc.duke.edu    
Principal Investigator: Alexander Limkakeng, MD            
Sub-Investigator: Joseph Govert, MD            
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Theodore R. Delbridge, MD     252-744-1418     delbridget@ecu.edu    
Contact: Allison Mainhart     252-744-5568     farmera@ecu.edu    
Principal Investigator: Theodore R. Delbridge, MD            
Sub-Investigator: Mark Mazer, MD            
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304-1619
Contact: Scott T Wilber, MD     330-375-7530     wilbers@summa-health.org    
Contact: Jennifer Frey, PhD, CCRP     330-375-7530     freyja@summa-health.org    
Principal Investigator: Scott T. Wilber, MD            
Miami Valley Hospital Withdrawn
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Penn State Hershey College of Medicine; Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Thomas Terndrup, MD     717-531-8955     tterndrup@hmc.psu.edu    
Contact: Arash Arvin     717-531-1707 ext 7     aarvin@hmc.psu.edu    
Principal Investigator: Thomas Terndrup, MD            
Sub-Investigator: Margaret M Wojnar, MD            
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Jacob Ufberg, MD     215-707-7550     ufbergjw@tuhs.temple.edu    
Contact: Kimberly Dehnkamp     215-707-3030     kimberly.dehnkamp@tuhs.temple.edu    
Principal Investigator: Jacob Ufberg, MD            
Sub-Investigator: John M. Travaline, MD            
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Scott R. Gunn, MD     412-647-9247     gunnsr@ccm.upmc.edu    
Contact: Pamela Fazio, RN, CRC     412-864-2069     faziop@upmc.edu    
Principal Investigator: Scott R. Gunn, MD            
Sub-Investigator: Brian Suffoletto            
UPMC Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Richard Wadas         wadasrj@upmc.edu    
Principal Investigator: Richard Wadas            
Sub-Investigator: Victor Okwiya Okwiya            
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Arvind Venkat, MD     412-359-8066     avenkat@wpahs.org    
Contact: Sue Anne Livingston     412-359-8763     saliving@wpahs.org    
Principal Investigator: Arvind Venkat, MD            
Sub-Investigator: Marvin Balaan, MD            
York Hospital Withdrawn
York, Pennsylvania, United States, 17405
United States, Tennessee
Vanderbilt University Medical Center Terminated
Nashville, Tennessee, United States, 37403
United States, Texas
University Medical Center Brackenridge Recruiting
Austin, Texas, United States, 78752
Contact: Sohan Parekh, MD         sohan.parekh@gmail.com    
Contact: Laura LaChance, MA, CCRP     512-610-0342     laura@researchhpcr.com    
Principal Investigator: Sohan Parekh, MD            
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Edward J. Kimball, MD     801-581-2088     Edward.kimball@hsc.utah.edu    
Contact: Mary Catherine Mone, RN     801- 581-4594     Mary.mone@hsc.utah.edu    
Principal Investigator: Edward J. Kimball, MD            
Sub-Investigator: Estelle Harris            
Intermountain Medical Center Recruiting
Salt Lake City, Utah, United States, 84157
Contact: Todd Allen, MD     801-507-6667     Todd.allen@intermountain.org    
Contact: Ben Briggs, BS     801-507-4770     Ben.briggs@intermountain.org    
Principal Investigator: Todd Allen, MD            
Sub-Investigator: Colin Grissom, MD            
Sponsors and Collaborators
University of Pittsburgh
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Derek C. Angus, MD, MPH University of Pittsburgh
Principal Investigator: John A. Kellum, MD University of Pittsburgh
Principal Investigator: Donald M. Yealy, MD University of Pittsburgh
  More Information

Additional Information:
ProCESS Study Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00510835     History of Changes
Other Study ID Numbers: P50 GM076659
Study First Received: July 18, 2007
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
septic shock
resuscitation
sepsis
cost-effectiveness
 sepsis-induced organ dysfunction
early goal directed therapy
emergency medicine
critical care medicine

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
 Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013