CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,351 enrolled
Drug / intervention
Early Goal Directed Therapy (EGDT) +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00510835
NCT00510835N/ACompleted
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Protocolized Care for Early Septic Shock

University of Pittsburgh·interventional·Posted Aug 2, 2007·Updated Jan 26, 2017

In Brief

A clinical study evaluating Early Goal Directed Therapy (EGDT), Protocolized Standard Care (PSC), and 1 other intervention for Sepsis and 2 related conditions. Completed, enrolled 1,351 participants across 31 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis, Severe Sepsis, Septic Shock
CountriesUnited States
CollaboratorsNational Institute of General Medical Sciences (NIGMS)

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2007
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.9 years ago

Interventions

Early Goal Directed Therapy (EGDT)procedure

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)procedure

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 (UC)procedure

Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices.