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Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation (LactATES)

Primary Purpose

Severe Sepsis, Septic Shock

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified EGDT
Standard EGDT
Sponsored by
National Institute of General Medical Sciences (NIGMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis, shock, emergency department, resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Cooper Hospital
  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Full Information

First Posted
September 6, 2006
Last Updated
January 12, 2009
Sponsor
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00372502
Brief Title
Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation
Acronym
LactATES
Official Title
Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
sepsis, shock, emergency department, resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Modified EGDT
Intervention Description
Early goal directed therapy with lactate clearance
Intervention Type
Procedure
Intervention Name(s)
Standard EGDT
Intervention Description
Early goal directed therapy
Primary Outcome Measure Information:
Title
Mortality
Time Frame
In-hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected infection Any two of four criteria of systemic inflammatory response SBP < 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate > 4 mmol/L (severe sepsis). Exclusion Criteria: Age < 18 years Pregnancy Established "Do Not Resuscitate" orders prior to enrollment Primary diagnosis other than sepsis Requirement for immediate surgery in < 6 hours from admission Any absolute contraindication to central venous catheterization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan E Jones, MD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeffrey A Kline, MD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Cooper Hospital
City
Camden
State/Province
New Jersey
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23740148
Citation
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.
Results Reference
derived
PubMed Identifier
20179283
Citation
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.
Results Reference
derived

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Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

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