Trial Outcomes & Findings for Protocolized Care for Early Septic Shock (NCT NCT00510835)

Last Updated: 2017-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1351 participants

Primary outcome timeframe

prior to discharge or 60 days, whichever comes first

Results posted on

2017-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	445	448	458
Overall Study COMPLETED	439	446	456
Overall Study NOT COMPLETED	6	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	6	2	2

Baseline Characteristics

Protocolized Care for Early Septic Shock

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Goal Directed Therapy (EGDT) n=439 Participants 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) n=446 Participants 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 n=456 Participants 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 n=1341 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 16.4 • n=5 Participants	61 years STANDARD_DEVIATION 16.1 • n=7 Participants	62 years STANDARD_DEVIATION 16.0 • n=5 Participants	61 years STANDARD_DEVIATION 16.2 • n=4 Participants
Gender Female	207 Participants n=5 Participants	194 Participants n=7 Participants	192 Participants n=5 Participants	593 Participants n=4 Participants
Gender Male	232 Participants n=5 Participants	252 Participants n=7 Participants	264 Participants n=5 Participants	748 Participants n=4 Participants
Region of Enrollment United States	439 participants n=5 Participants	446 participants n=7 Participants	456 participants n=5 Participants	1341 participants n=4 Participants

PRIMARY outcome

Timeframe: prior to discharge or 60 days, whichever comes first

Outcome measures

Outcome measures
Measure	Early Goal Directed Therapy (EGDT) n=439 Participants 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) n=446 Participants 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 n=456 Participants 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.
Hospital Mortality	92 Participants	81 Participants	86 Participants

SECONDARY outcome

Timeframe: study hour 0, 6, 24 & 72

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at discharge or 60 days, whichever comes first

Outcome measures

Outcome data not reported

Adverse Events

Early Goal Directed Therapy (EGDT)

Serious events: 23 serious events

Other events: 41 other events

Deaths: 0 deaths

Protocolized Standard Care (PSC)

Serious events: 22 serious events

Other events: 49 other events

Deaths: 0 deaths

Usual Care

Serious events: 37 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Early Goal Directed Therapy (EGDT) n=439 participants at risk 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) n=446 participants at risk 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 n=456 participants at risk 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.
Cardiac disorders cardiac dysfunction	1.6% 7/439 • 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.	1.1% 5/446 • 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.	1.5% 7/456 • 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.
Gastrointestinal disorders gastrointestinal	0.00% 0/439 • 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.	0.00% 0/446 • 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.	0.44% 2/456 • 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.
Gastrointestinal disorders hemorrhage/bleeding	0.00% 0/439 • 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.	0.00% 0/446 • 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.	0.22% 1/456 • 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.
Hepatobiliary disorders hepatobiliary/pancreas	0.00% 0/439 • 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.	0.45% 2/446 • 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.	0.66% 3/456 • 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.
Infections and infestations Infection	0.23% 1/439 • 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.	0.67% 3/446 • 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.	0.44% 2/456 • 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.
Metabolism and nutrition disorders Metabolic/laboratory	0.46% 2/439 • 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.	0.67% 3/446 • 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.	0.66% 3/456 • 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.
Nervous system disorders neurology	0.46% 2/439 • 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.	0.45% 2/446 • 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.	0.22% 1/456 • 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.
General disorders pain	0.00% 0/439 • 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.	0.00% 0/446 • 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.	0.22% 1/456 • 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.
Respiratory, thoracic and mediastinal disorders pulmonary/upper respiratory	1.1% 5/439 • 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.	1.1% 5/446 • 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.	2.2% 10/456 • 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.
Renal and urinary disorders renal/genitourinary	1.1% 5/439 • 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.	0.22% 1/446 • 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.	1.1% 5/456 • 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.
Vascular disorders vascular	0.23% 1/439 • 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.	0.22% 1/446 • 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.	0.44% 2/456 • 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.

Other adverse events

Additional Information

Derek C. Angus, MD, MPH, FRCP

UPittsburgh

Phone: (412) 647-6965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place