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Protocolized Care for Early Septic Shock (ProCESS)
This study is currently recruiting participants.
Verified by National Institute of General Medical Sciences (NIGMS), September 2008
Sponsors and Collaborators: National Institute of General Medical Sciences (NIGMS)
University of Pittsburgh
Information provided by: National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00510835
  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)

MedlinePlus related topics: Sepsis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Protocolized Care for Early Septic Shock

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

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: 1935
Study Start Date: March 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: Experimental
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.
3: Active Comparator
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:

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.

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.

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.

  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 20 ml/kg 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: Diana K. Stapleton, RN,BSBM,CCRC 412-647-3689 stapletondk@upmc.edu

Locations
United States, Alabama
Universtiy of Alabama Recruiting
Birmingham, Alabama, United States, 35249
Contact: Jason R. Begue, MD     205-975-7387     jbegue@uabmc.edu    
Contact: Robin Lai, BS     205-996-7338     kali@uabmc.edu    
Principal Investigator: Jason R. Begue, MD            
Sub-Investigator: Jennifer J. Davis, 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, California
LA County & USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Howard Belzberg, MD     323-226-7798     belzberg@usc.edu    
Contact: Danila Oder     323-226-7798     doder@usc.edu    
Principal Investigator: Howard Belzberg, MD            
Sub-Investigator: Stuart Swadron, MD            
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Edward A. Panacek, MD, MPH     916-734-8569     eapanacek@ucdavis.edu    
Contact: Abhi Gorhe, MBBS     916-734-8567     abhijeet.gorhe@ucdmc.ucdavis.edu    
Principal Investigator: Edward A. Panacek, MD, MPH            
Sub-Investigator: Timothy E. Albertson, MD, PhD            
Stanford University School of Medicine Not yet recruiting
Palo Alto, California, United States, 94025
Contact: Ronald G. Pearl, MD, PhD     650-723-5024     rgp@stanford.edu    
Contact: Geraldine O'Riordan     650-498-6210     gor@stanford.edu    
Principal Investigator: Ronald G. Pearl, MD, PhD            
Sub-Investigator: Matthew Strehlow, MD            
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 Recruiting
Washington, District of Columbia, United States, 20037
Contact: Lakmir Chawla, MD     202-715-4570     lchawla@mfa.gwu.edu    
Contact: Christina Seneff     202-715-5257     cseneff@mfa.gwu.edu    
Principal Investigator: Lakmir Chawla, MD            
Sub-Investigator: Larissa May, 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: Daryl DeNittis, RN     813-933-7364     ddenittis@aol.com    
Principal Investigator: David Orban, MD            
Sub-Investigator: Richard Paula, MD            
United States, Indiana
Methodist Research Institute Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Timothy Ellender, MD     317-962-5975     tellender@clarian.org    
Contact: Susan Becka, RN     317-962-2037     sbecka@clarian.org    
Principal Investigator: Timothy Ellender, MD            
Sub-Investigator: Christopher Naum, MD            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Filbin, MD     617-724-0348     nfilbin@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         sparpmar@partners.org    
Principal Investigator: Peter C. Hou, MD            
Sub-Investigator: Anthony Massaro, MD            
United States, New York
North Shore University Hospital Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Todd Slessinger, MD     516-562-2426     tslessinger@yahoo.com    
Contact: Jean Ayan, RN     516-562-2426     jayan@nshs.edu    
Principal Investigator: Andrew Sama, MD            
Sub-Investigator: Todd Slesinger, MD            
State University of New York Recruiting
Brooklyn, New York, United States, 11203
Contact: Richard Sinert, DO     718-245-2973     nephron1@bellatlantic.net    
Contact: Ramanand Subramanian, MD     301-346-6220     srarun31@gmail.com    
Principal Investigator: Richard Sinert, DO            
Sub-Investigator: Spencer Nabors, 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 Not yet recruiting
Greenville, North Carolina, United States, 27705
Contact: Theodore R. Delbridge, MD     252-744-1418     delbridge@ecu.edu    
Contact: Kori Brewer, PhD     252-744-2158        
Principal Investigator: Theodore R. Delbridge, MD            
Sub-Investigator: Mark Mazer, MD            
United States, Ohio
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Aashish Patel, MD     216-778-8911     apatel@metrohealth.org    
Contact: Julie Nichols, RN     216-957-6488     jnichols@metrohealth.org    
Principal Investigator: Aashish Patel, MD            
Sub-Investigator: Ziad Shaman, MD            
Ohio State University Medical Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Jeffrey Caterino, MD     614-293-3446     jeffrey.caterino@osumc.edu    
Contact: Lynn White, MS     614-293-5102     lynn.white@osumc.edu    
Principal Investigator: Jeffrey Caterino, MD            
Sub-Investigator: Naeem Ali, MD            
United States, Pennsylvania
Temple University Hospital Not yet 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: Barbara Early, RN     412-647-9745     earlybj@upmc.edu    
Principal Investigator: Scott R. Gunn, MD            
Sub-Investigator: Donald M. Yealy, 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 C. Mone     (801) 581-4594     mary.mone@hsc.utah.edu    
Principal Investigator: Edward J. Kimball, MD            
Sub-Investigator: David Fosnocht, MD            
Intermountain Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
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
National Institute of General Medical Sciences (NIGMS)
University of Pittsburgh
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

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

Publications:
Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77.
Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10.
Kochanek KD, Smith BL. Deaths: preliminary data for 2002. Natl Vital Stat Rep. 2004 Feb 11;52(13):1-47.
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. Review.
Rivers EP, Ander DS, Powell D. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care. 2001 Jun;7(3):204-11. Review.
Feezor RJ, Baker HV, Mindrinos M, Hayden D, Tannahill CL, Brownstein BH, Fay A, MacMillan S, Laramie J, Xiao W, Moldawer LL, Cobb JP, Laudanski K, Miller-Graziano CL, Maier RV, Schoenfeld D, Davis RW, Tompkins RG; Inflammation and Host Response to Injury, Large-Scale Collaborative Research Program. Whole blood and leukocyte RNA isolation for gene expression analyses. Physiol Genomics. 2004 Nov 17;19(3):247-54.
Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter. A randomized, controlled trial. Ann Intern Med. 1997 Aug 15;127(4):257-66.
Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. Erratum in: N Engl J Med. 2007 Jun 21;356(25):2660.
McGee WT, Ackerman BL, Rouben LR, Prasad VM, Bandi V, Mallory DL. Accurate placement of central venous catheters: a prospective, randomized, multicenter trial. Crit Care Med. 1993 Aug;21(8):1118-23.
Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts--blood transfusion. N Engl J Med. 1999 Feb 11;340(6):438-47. Review. No abstract available.
Dodd RY, Notari EP 4th, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion. 2002 Aug;42(8):975-9.
Dellinger RP. Cardiovascular management of septic shock. Crit Care Med. 2003 Mar;31(3):946-55. Review. No abstract available.
Hollenberg SM, Ahrens TS, Annane D, Astiz ME, Chalfin DB, Dasta JF, Heard SO, Martin C, Napolitano LM, Susla GM, Totaro R, Vincent JL, Zanotti-Cavazzoni S. Practice parameters for hemodynamic support of sepsis in adult patients: 2004 update. Crit Care Med. 2004 Sep;32(9):1928-48. Review.
Rady MY, Smithline HA, Blake H, Nowak R, Rivers E. A comparison of the shock index and conventional vital signs to identify acute, critical illness in the emergency department. Ann Emerg Med. 1994 Oct;24(4):685-90. Erratum in: Ann Emerg Med 1994 Dec;24(6):1208.
Yealy DM, Delbridge TR. The shock index: all that glitters... Ann Emerg Med. 1994 Oct;24(4):714-5. No abstract available.
Rady MY, Rivers EP, Nowak RM. Resuscitation of the critically ill in the ED: responses of blood pressure, heart rate, shock index, central venous oxygen saturation, and lactate. Am J Emerg Med. 1996 Mar;14(2):218-25.

Responsible Party: University of Pittsburgh ( Derek C. Angus, MD, MPH )
Study ID Numbers: P50 GM076659
Study First Received: July 18, 2007
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00510835  
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
septic shock
resuscitation
sepsis
cost-effectiveness
 sepsis-induced organ dysfunction
early goal directed therapy
emergency medicine
critical care medicine

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Shock
 Shock, Septic
Emergencies
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009



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