Immunomodulatory Properties of Ketamine in Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01089361
First received: March 12, 2010
Last updated: October 19, 2010
Last verified: October 2010

March 12, 2010
October 19, 2010
December 2009
June 2010   (final data collection date for primary outcome measure)
Serum levels of IL-6, IL-10 and TNFα and other cytokines [ Time Frame: first 7 days of admission ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01089361 on ClinicalTrials.gov Archive Site
  • Adverse effects attributable to ketamine [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Organ failures [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Incidence of new organ failure as detected by Sequential Organ Failure Assessment [SOFA] score. Definitions are as follows. Central nervous system: delirium, coma, uncontrollable seizures, ICP>20cm H2O Cardiac: MAP <60mmHg, blood pressure supported with pressors, 50 > HR > 120 Respiratory: vented, RR>30, PaO2<60, PaCO2 > 55, Sat<92% Kidney: RIFLE criteria Anemia: Hct<27, transfusion of PRBC Thrmobocytopenia: platelet < 50k, platelet transfusion Liver: biopsy, ALT>200, AST>200, t.bil>2.0, ALP>300 Coaugulation failure: INR>2 if no anticoagulation therapy
  • Daily Acute Physiology and Chronic Health Evaluation (APACHE) scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Difference in average APACHE-II score between the intervention and placebo groups. The point score is calculated from 12 routine physiological measurements (such as blood pressure, body temperature, heart rate etc.) during the first 24 hours after admission, information about previous health status and some information obtained at admission (such as age).
  • Length of intensive care unit (ICU) stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Adverse effects attributable to ketamine [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Organ failures [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Incidence of new organ failure as detected by Sequential Organ Failure Assessment [SOFA] score.
  • Daily Acute Physiology and Chronic Health Evaluation (APACHE) scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Difference in average APACHE-II score between the intervention and placebo groups.
  • Length of intensive care unit (ICU) stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immunomodulatory Properties of Ketamine in Sepsis
Immunomodulatory Properties of Ketamine in Sepsis

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sepsis
  • Drug: Ketamine
    The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
  • Drug: Normal Saline placebo
    The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
  • Placebo Comparator: Normal saline
    The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
    Intervention: Drug: Normal Saline placebo
  • Experimental: Ketamine
    The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
    Intervention: Drug: Ketamine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
June 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01089361
2009-P-000259
No
Daniel Talmor, MD, MPH, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: Daniel Talmor, MD, MPH Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP