Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.

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Detailed Description

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Conditions

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Severe Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Standard EGDT

Intervention Type PROCEDURE

Early goal directed therapy

2

Group Type EXPERIMENTAL

Modified EGDT

Intervention Type PROCEDURE

Early goal directed therapy with lactate clearance

Interventions

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Modified EGDT

Early goal directed therapy with lactate clearance

Intervention Type PROCEDURE

Standard EGDT

Early goal directed therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Suspected infection
2. Any two of four criteria of systemic inflammatory response
3. SBP \< 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate \> 4 mmol/L (severe sepsis).

Exclusion Criteria

1. Age \< 18 years
2. Pregnancy
3. Established "Do Not Resuscitate" orders prior to enrollment
4. Primary diagnosis other than sepsis
5. Requirement for immediate surgery in \< 6 hours from admission
6. Any absolute contraindication to central venous catheterization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No