Immunomodulatory Properties of Ketamine in Sepsis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Sepsis

In brief

The aim of the study is to assess the effect of short-term infusion of ketamine at analgesic dosage on the immune response, morbidity and mortality among patients suffering from septic shock. We hypothesize that ketamine will modulate the cytokine response to sepsis and reduce morbidity and mortality.

Key facts

Study ID

NCT01089361

Run by

Beth Israel Deaconess Medical Center

People needed

19

Starts

2009-12-01

Expected to finish

2011-06-01

Last updated by the study team

2017-08-21

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients meeting the ACCP/ SCCM definition of severe sepsis will be enrolled in the study. These patients should have a known or suspected source of infection.
• Patients within 12 hours of the development of one or more organ dysfunctions
• Patients must exhibit 3 or more of the following signs of clinical inflammation:
• Core temperature < 36ºC or > 38ºC.
• Heart rate of 90 or greater not explained by another medical condition.
• A respiratory rate of > 20 min-1, a PaCO2 < 32min-1 or the need for mechanical ventilation.
• A white blood cell count of < 4000 cell/ml or > 12000 cells/ml or a WBC showing greater then 10% immature neutrophils.

You may not qualify if…

• pregnant
• increased intracranial pressure or closed head injury
• history of psychotic mental disease
• receiving Continuous Veno - Venous Hemofiltration

Where it is running

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

Full record on ClinicalTrials.gov

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