Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

Septic Shock Clinical Trial

— LactATES  

Official title:

Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372502
• Other study ID #: 1K23GM076652
• Status: Completed
• Phase: N/A
• First received: September 6, 2006
• Last updated: January 12, 2009
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Toxemia

Intervention

Procedure:
• Modified EGDT
Early goal directed therapy with lactate clearance
• Standard EGDT
Early goal directed therapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cooper Hospital	Camden	New Jersey
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		In-hospital	No