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Protocolized Care for Early Septic Shock

NCT00510835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1351

Last updated 2017-01-26

Study results available
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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.

Conditions

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Interventions

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.

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.

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.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Derek C. Angus, MD, MPH · University of Pittsburgh

  • John A. Kellum, MD · University of Pittsburgh

  • Donald M. Yealy, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2013-07-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00510835 on ClinicalTrials.gov