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CompletedNCT00372502LactATESUpdated Jan 14, 2009

Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

An interventional study of Modified EGDT and Standard EGDT in Severe Sepsis and Septic Shock, sponsored by National Institute of General Medical Sciences (NIGMS). Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-14.

Sponsored by National Institute of General Medical Sciences (NIGMS) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Severe Sepsis
  • Septic Shock

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Keywords

  • sepsis
  • shock
  • emergency department
  • resuscitation
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 300 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

National Institute of General Medical Sciences (NIGMS) is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    1

    Procedure: Standard EGDT

  • Experimental
    2

    Procedure: Modified EGDT

Interventions

  • ProcedureModified EGDT

    Early goal directed therapy with lactate clearance

  • ProcedureStandard EGDT

    Early goal directed therapy

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What researchers measure

Primary outcomes

  1. Mortality

    Time frame: In-hospital

07

Study locations

3 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
  • Cooper Hospital
    Camden, New Jersey, United States
  • Carolinas Medical Center
    Charlotte, North Carolina, United States
08

References and documents

Publications

  • Puskarich MA, Trzeciak S, Shapiro NI, Albers AB, Heffner AC, Kline JA, Jones AE. Whole blood lactate kinetics in patients undergoing quantitative resuscitation for severe sepsis and septic shock. Chest. 2013 Jun;143(6):1548-1553. doi: 10.1378/chest.12-0878. PubMed 23740148 ↗
  • Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158. PubMed 20179283 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00372502
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
First posted
Sep 7, 2006
Start date
Jan 2007
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jan 14, 2009

Study contacts

Alan E Jones, MD
study director · Carolinas Medical Center
Jeffrey A Kline, MD
study chair · Carolinas Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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