Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation - Full Text View

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

This study is currently recruiting participants.
Verified by National Institute of General Medical Sciences (NIGMS), January 2007

Sponsored by:	National Institute of General Medical Sciences (NIGMS)
Information provided by:	National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:	NCT00372502

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

MedlinePlus related topics:

Sepsis

ChemIDplus related topics:

Lactic acid Ammonium lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

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

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 ]

Estimated Enrollment:	300
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Procedure: Standard EGDT Early goal directed therapy
2: Experimental	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

Contacts


Contact: Alan E Jones, MD	704-355-7092	alan.jones@carolinas.org

Locations


United States, Massachusetts
	Beth Israel Deaconess Medical Center	Recruiting
	Boston, Massachusetts, United States
	Contact: Nathan I Shapiro, MD, MPH
	Principal Investigator: Nathan I Shapiro, MD, MPH

United States, New Jersey
	Cooper Hospital	Recruiting
	Camden, New Jersey, United States
	Contact: Stephen Trzeciak, MD, MPH
	Principal Investigator: Stephen Trzeciak, MD, MPH
	Sub-Investigator: Ryan Arnold, MD

United States, North Carolina
	Carolinas Medical Center	Recruiting
	Charlotte, North Carolina, United States
	Contact: Alan E Jones, MD alan.jones@carolinas.org
	Principal Investigator: Alan E Jones, MD

Sponsors and Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators


Study Director:	Alan E Jones, MD	Carolinas Medical Center

Study Chair:	Jeffrey A Kline, MD	Carolinas Medical Center

More Information

Emergency Medicine Shock Research Network This link exits the ClinicalTrials.gov site

Responsible Party:	Carolinas Medical Center ( Alan E Jones, MD; Assistant Research Director )
Study ID Numbers:	1K23GM076652
First Received:	September 6, 2006
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00372502
Health Authority:	United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):

sepsis

shock

emergency department

resuscitation

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Sepsis

Shock

Shock, Septic

Emergencies

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Infection

ClinicalTrials.gov processed this record on October 16, 2008