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Completed

NCT Number: NCT00372502

Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

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.

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Key information

Conditions

Severe Sepsis Disease Attributes Emergencies Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified EGDT

Procedure

Early goal directed therapy with lactate clearance

Standard EGDT

Procedure

Early goal directed therapy

Primary outcomes

  1. Mortality

    Time frame: In-hospital

Sponsors and collaborators

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Nih

Registry information

Official study title

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

Acronym: LactATES

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 7, 2006
Registry last updated
Jan 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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