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
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Severe Sepsis Septic Shock||Procedure: Early Goal Directed Therapy (EGDT) Procedure: Protocolized Standard Care (PSC) Procedure: Usual Care (UC)||Not Applicable|
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.
- 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1351 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protocolized Care for Early Septic Shock|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||December 2013|
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.
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.
- Hospital Mortality [ Time Frame: 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.
- Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis. [ Time Frame: study hour 0, 6, 24 & 72 ]
- Resource Use and Costs of Alternative Resuscitation Strategies [ Time Frame: at discharge or 60 days, whichever comes first ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510835
|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|