This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Protocolized Care for Early Septic Shock (ProCESS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Derek C. Angus, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00510835
First received: July 18, 2007
Last updated: December 1, 2016
Last verified: December 2016
Results First Received: December 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Sepsis
Severe Sepsis
Septic Shock
Interventions: Procedure: Early Goal Directed Therapy (EGDT)
Procedure: Protocolized Standard Care (PSC)
Procedure: Usual Care (UC)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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.

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.

Usual Care

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.

Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices.


Participant Flow:   Overall Study
    Early Goal Directed Therapy (EGDT)   Protocolized Standard Care (PSC)   Usual Care
STARTED   445   448   458 
COMPLETED   439   446   456 
NOT COMPLETED   6   2   2 
Withdrawal by Subject                6                2                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.

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.

Usual Care

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.

Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices.

Total Total of all reporting groups

Baseline Measures
   Early Goal Directed Therapy (EGDT)   Protocolized Standard Care (PSC)   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 439   446   456   1341 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (16.4)   61  (16.1)   62  (16.0)   61  (16.2) 
Gender 
[Units: Participants]
Count of Participants
       
Female      207  47.2%      194  43.5%      192  42.1%      593  44.2% 
Male      232  52.8%      252  56.5%      264  57.9%      748  55.8% 
Region of Enrollment 
[Units: Participants]
       
United States   439   446   456   1341 


  Outcome Measures

1.  Primary:   Hospital Mortality   [ Time Frame: prior to discharge or 60 days, whichever comes first ]

2.  Secondary:   Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.   [ Time Frame: study hour 0, 6, 24 & 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Resource Use and Costs of Alternative Resuscitation Strategies   [ Time Frame: at discharge or 60 days, whichever comes first ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Derek C. Angus, MD, MPH, FRCP
Organization: UPittsburgh
phone: (412) 647-6965
e-mail: angusdc@ccm.upmc.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Derek C. Angus, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00510835     History of Changes
Other Study ID Numbers: P50GM076659 ( U.S. NIH Grant/Contract )
Study First Received: July 18, 2007
Results First Received: December 1, 2016
Last Updated: December 1, 2016