Immunomodulatory Properties of Ketamine in Sepsis

Condition(s) targeted: Sepsis

Intervention: Ketamine (Drug); Normal Saline placebo (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Daniel Talmor, MD, MPH, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

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.

Official title: Immunomodulatory Properties of Ketamine in Sepsis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Serum levels of IL-6, IL-10 and TNFα and other cytokines

Secondary outcome:

Adverse effects attributable to ketamine

Organ failures

Daily Acute Physiology and Chronic Health Evaluation (APACHE) scores

Length of intensive care unit (ICU) stay

28 day mortality

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Related publications:

Calandra T, Bochud PY, Heumann D. Cytokines in septic shock. Curr Clin Top Infect Dis. 2002;22:1-23. Review.

Laudanski K, Miller-Graziano C, Xiao W, Mindrinos MN, Richards DR, De A, Moldawer LL, Maier RV, Bankey P, Baker HV, Brownstein BH, Cobb JP, Calvano SE, Davis RW, Tompkins RG. Cell-specific expression and pathway analyses reveal alterations in trauma-related human T cell and monocyte pathways. Proc Natl Acad Sci U S A. 2006 Oct 17;103(42):15564-9. Epub 2006 Oct 10.

Kawasaki T, Ogata M, Kawasaki C, Ogata J, Inoue Y, Shigematsu A. Ketamine suppresses proinflammatory cytokine production in human whole blood in vitro. Anesth Analg. 1999 Sep;89(3):665-9.

Starting date: December 2009
Last updated: October 19, 2010