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Trial record 1 of 1 for:    NCT00510835
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Protocolized Care for Early Septic Shock (ProCESS)

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ClinicalTrials.gov Identifier: NCT00510835
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Derek C. Angus, MD, MPH, University of Pittsburgh

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)
Enrollment 1351
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care
Hide Arm/Group Description

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)- 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 - 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.

Period Title: Overall Study
Started 445 448 458
Completed 439 446 456
Not Completed 6 2 2
Reason Not Completed
Withdrawal by Subject             6             2             2
Arm/Group Title Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care Total
Hide Arm/Group Description

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)- 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 - 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 of all reporting groups
Overall Number of Baseline Participants 439 446 456 1341
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 439 participants 446 participants 456 participants 1341 participants
60  (16.4) 61  (16.1) 62  (16.0) 61  (16.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 439 participants 446 participants 456 participants 1341 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 439 participants 446 participants 456 participants 1341 participants
439 446 456 1341
1.Primary Outcome
Title Hospital Mortality
Hide Description 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.
Time Frame prior to discharge or 60 days, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care
Hide Arm/Group Description:

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)- 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 - 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.

Overall Number of Participants Analyzed 439 446 456
Measure Type: Count of Participants
Unit of Measure: Participants
92
  21.0%
81
  18.2%
86
  18.9%
2.Secondary Outcome
Title Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.
Hide Description [Not Specified]
Time Frame study hour 0, 6, 24 & 72
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Resource Use and Costs of Alternative Resuscitation Strategies
Hide Description [Not Specified]
Time Frame at discharge or 60 days, whichever comes first
Outcome Measure Data Not Reported
Time Frame Adverse events were reported following the protocol guidelines: 1. Detailed information was collected regarding all SAEs that occurred during ProCESS study hours 0-72 2. Ongoing SAE information was collected for events related to the study PreSep line for the duration of the hospital stay or day 60 (whichever came 1st) 3. After hour 72, all SAEs that investigators considered potentially related to the study intervention were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care
Hide Arm/Group Description

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)- 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 - 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.

All-Cause Mortality
Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/439 (5.24%)   22/446 (4.93%)   37/456 (8.11%) 
Cardiac disorders       
cardiac dysfunction * 1  7/439 (1.59%)  5/446 (1.12%)  7/456 (1.54%) 
Gastrointestinal disorders       
gastrointestinal * 1  0/439 (0.00%)  0/446 (0.00%)  2/456 (0.44%) 
hemorrhage/bleeding * 1  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
General disorders       
pain * 1 [1]  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
Hepatobiliary disorders       
hepatobiliary/pancreas * 1  0/439 (0.00%)  2/446 (0.45%)  3/456 (0.66%) 
Infections and infestations       
Infection * 1  1/439 (0.23%)  3/446 (0.67%)  2/456 (0.44%) 
Metabolism and nutrition disorders       
Metabolic/laboratory * 1  2/439 (0.46%)  3/446 (0.67%)  3/456 (0.66%) 
Nervous system disorders       
neurology * 1  2/439 (0.46%)  2/446 (0.45%)  1/456 (0.22%) 
Renal and urinary disorders       
renal/genitourinary * 1  5/439 (1.14%)  1/446 (0.22%)  5/456 (1.10%) 
Respiratory, thoracic and mediastinal disorders       
pulmonary/upper respiratory * 1  5/439 (1.14%)  5/446 (1.12%)  10/456 (2.19%) 
Vascular disorders       
vascular * 1  1/439 (0.23%)  1/446 (0.22%)  2/456 (0.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Pain NOS
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early Goal Directed Therapy (EGDT) Protocolized Standard Care (PSC) Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/439 (9.34%)   49/446 (10.99%)   52/456 (11.40%) 
Blood and lymphatic system disorders       
blood/bone marrow * 1  5/439 (1.14%)  7/446 (1.57%)  8/456 (1.75%) 
coagulation * 1  2/439 (0.46%)  2/446 (0.45%)  0/456 (0.00%) 
lymphatics * 1  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
Cardiac disorders       
cardiac dysfunction * 1  8/439 (1.82%)  7/446 (1.57%)  5/456 (1.10%) 
Endocrine disorders       
endocrine * 1  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
Eye disorders       
ocular/visual * 1  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
Gastrointestinal disorders       
gastrointestinal * 1  3/439 (0.68%)  2/446 (0.45%)  3/456 (0.66%) 
hemorrhage/bleeding * 1  0/439 (0.00%)  1/446 (0.22%)  1/456 (0.22%) 
General disorders       
pain * 1  1/439 (0.23%)  1/446 (0.22%)  0/456 (0.00%) 
Hepatobiliary disorders       
hepatobiliary/pancreas * 1  1/439 (0.23%)  2/446 (0.45%)  0/456 (0.00%) 
Immune system disorders       
allergy/immunology * 1  0/439 (0.00%)  1/446 (0.22%)  1/456 (0.22%) 
Infections and infestations       
infection * 1  1/439 (0.23%)  3/446 (0.67%)  3/456 (0.66%) 
Metabolism and nutrition disorders       
metabolic/laboratory * 1  3/439 (0.68%)  8/446 (1.79%)  14/456 (3.07%) 
Nervous system disorders       
neurology * 1  2/439 (0.46%)  2/446 (0.45%)  3/456 (0.66%) 
Renal and urinary disorders       
renal/genitourinary * 1  2/439 (0.46%)  2/446 (0.45%)  1/456 (0.22%) 
Respiratory, thoracic and mediastinal disorders       
pulmonary/upper respiratory * 1  9/439 (2.05%)  11/446 (2.47%)  3/456 (0.66%) 
Skin and subcutaneous tissue disorders       
dermatology/skin * 1  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
Surgical and medical procedures       
hematoma * 1 [1]  0/439 (0.00%)  0/446 (0.00%)  1/456 (0.22%) 
Line issue * 1 [2]  1/439 (0.23%)  0/446 (0.00%)  0/456 (0.00%) 
Vascular disorders       
vascular * 1  3/439 (0.68%)  0/446 (0.00%)  5/456 (1.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
While remaining in the ICU, the subject developed a large hematoma in the right groin at the site of the femoral line and the line was removed. As this arm of the study is observational only this adverse event is considered unrelated to the study.
[2]
Old line removed but unable to thread new line resulting in loss of CVL. Unable to access R IJ as shunt in place. Pt was to have central line surgically for hypotension, places upon admission to ICU and was determined not meet the criteria for SAE.
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
Layout table for Results Point of Contact information
Name/Title: Derek C. Angus, MD, MPH, FRCP
Organization: UPittsburgh
Phone: (412) 647-6965
EMail: angusdc@ccm.upmc.edu
Publications:
Layout table for additonal information
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 )
First Submitted: July 18, 2007
First Posted: August 2, 2007
Results First Submitted: December 1, 2016
Results First Posted: January 26, 2017
Last Update Posted: January 26, 2017