Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Sepsis
Drug: Ketamine
Drug: Normal Saline placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunomodulatory Properties of Ketamine in Sepsis

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Serum levels of IL-6, IL-10 and TNFα and other cytokines [ Time Frame: first 7 days of admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089361

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Daniel Talmor, MD, MPH Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Daniel Talmor, MD, MPH, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01089361     History of Changes
Other Study ID Numbers: 2009-P-000259
Study First Received: March 12, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
systemic inflammatory syndrome
sepsis syndrome
septic shock
Cytokine
Ketamine

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Ketamine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014