CompletedPhase 1ketamine

Immunomodulatory Properties of Ketamine in Sepsis

NCT ID

NCT01089361

Target Enrollment

19 participants

Start Date

2009-12

Est. Completion

2011-06

About This Study

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.

Conditions Studied

Sepsis

Interventions

•Ketamine
•Normal Saline placebo

Eligibility

Age:21 Years - 100 Years

Healthy Volunteers:No

View full eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Study Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States