Overview

This trial is active, not recruiting.

Condition sepsis
Treatments ketamine, normal saline placebo
Phase phase 1/phase 2
Sponsor Beth Israel Deaconess Medical Center
Start date December 2009
End date June 2010
Trial size 32 participants
Trial identifier NCT01089361, 2009-P-000259

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
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)
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.
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.

Primary Outcomes

Measure
Serum levels of IL-6, IL-10 and TNFα and other cytokines
time frame: first 7 days of admission

Secondary Outcomes

Measure
Adverse effects attributable to ketamine
time frame: 7 days
Organ failures
time frame: 7 days
Daily Acute Physiology and Chronic Health Evaluation (APACHE) scores
time frame: 7 days
Length of intensive care unit (ICU) stay
time frame: 28 days
28 day mortality
time frame: 28 days

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Immunomodulatory Properties of Ketamine in Sepsis
Principal investigator Daniel Talmor, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.