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Immunomodulatory Properties of Ketamine in Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089361
First Posted: March 18, 2010
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Talmor, Beth Israel Deaconess Medical Center
Results First Submitted: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sepsis
Interventions: Drug: Ketamine
Drug: Normal Saline placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between 2009 and 2010 from the ICU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients who consented were randomized to treatment or placebo.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Normal Saline   Ketamine
STARTED   9   10 
COMPLETED   8   10 
NOT COMPLETED   1   0 
Death                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Normal Saline   Ketamine   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   10   19 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  33.3%      6  60.0%      9  47.4% 
>=65 years      6  66.7%      4  40.0%      10  52.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (19)   60  (11)   61  (15) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  22.2%      2  20.0%      4  21.1% 
Male      7  77.8%      8  80.0%      15  78.9% 
Region of Enrollment 
[Units: Participants]
     
United States   9   10   19 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum Levels of IL-6, IL-10 and TNFα   [ Time Frame: first 7 days of admission, Baseline and Day 7 reported ]

2.  Secondary:   Adverse Effects Attributable to Ketamine   [ Time Frame: 7 days ]

3.  Secondary:   Organ Failures   [ Time Frame: 7 days ]

4.  Secondary:   Acute Physiology and Chronic Health Evaluation (APACHE) Scores   [ Time Frame: First 24 hours after ICU admission ]

5.  Secondary:   Length of Intensive Care Unit (ICU) Stay   [ Time Frame: 28 days ]

6.  Secondary:   28 Day Mortality   [ Time Frame: 28 days ]

7.  Other Pre-specified:   PCR Substudy   [ Time Frame: Daily up to 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel Talmor
Organization: Beth Israel Deaconess Medical Center
phone: 617-754-2675
e-mail: dtalmor@bidmc.harvard.edu


Publications:

Responsible Party: Daniel Talmor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01089361     History of Changes
Other Study ID Numbers: 2009P000259
First Submitted: March 12, 2010
First Posted: March 18, 2010
Results First Submitted: December 22, 2015
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017