Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation (LactATES)
This study has been completed.
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00372502
First received: September 6, 2006
Last updated: January 12, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Severe Sepsis Septic Shock |
Procedure: Modified EGDT Procedure: Standard EGDT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial |
Resource links provided by NLM:
Further study details as provided by National Institute of General Medical Sciences (NIGMS):
Primary Outcome Measures:
- Mortality [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
| Enrollment: | 300 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Procedure: Standard EGDT
Early goal directed therapy
|
| Experimental: 2 |
Procedure: Modified EGDT
Early goal directed therapy with lactate clearance
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372502
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States | |
| United States, New Jersey | |
| Cooper Hospital | |
| Camden, New Jersey, United States | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States | |
Sponsors and Collaborators
Investigators
| Study Director: | Alan E Jones, MD | Carolinas Medical Center |
| Study Chair: | Jeffrey A Kline, MD | Carolinas Medical Center |
More Information
Additional Information:
No publications provided by National Institute of General Medical Sciences (NIGMS)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alan E Jones, MD; Assistant Research Director, Carolinas Medical Center |
| ClinicalTrials.gov Identifier: | NCT00372502 History of Changes |
| Other Study ID Numbers: | 1K23GM076652 |
| Study First Received: | September 6, 2006 |
| Last Updated: | January 12, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of General Medical Sciences (NIGMS):
|
sepsis shock emergency department resuscitation |
Additional relevant MeSH terms:
|
Sepsis Toxemia Shock Shock, Septic |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013