Isoflurane Preconditioning for Liver Resections

This study has been terminated.
(We no longer had an appropriate patient population.Study closed)
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01031550
First received: December 10, 2009
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Liver Disease
Interventions: Drug: isoflurane
Other: standard of care

  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
Subjects will be randomized in two strata, those with and without preexisting liver disease. Subjects will be screened in pre admission testing

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects may withdraw consent

Reporting Groups
  Description
Standard Anesthetic Management standard anesthetic management
Preconditioning With 2 MAC Isoflurane Group preconditioning with isoflurane

Participant Flow:   Overall Study
    Standard Anesthetic Management     Preconditioning With 2 MAC Isoflurane Group  
STARTED     5     3  
COMPLETED     5     3  
NOT COMPLETED     0     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
Standard Anesthetic Management standard anesthetic management
Preconditioning With 2 MAC Isoflurane Group preconditioning with isoflurane
Total Total of all reporting groups

Baseline Measures
    Standard Anesthetic Management     Preconditioning With 2 MAC Isoflurane Group     Total  
Number of Participants  
[units: participants]
  5     3     8  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     3     7  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 10     38  ± 8     39  ± 9  
Gender  
[units: participants]
     
Female     2     1     3  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     5     3     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post Operative Complications Grade IIIb or Greater According to Clavien's Classification   [ Time Frame: first 7 post operative days ]

2.  Secondary:   Peak Postoperative AST, ALT and T Bili   [ Time Frame: first 7 post operative days ]

3.  Secondary:   Length of ICU and Hospital Stay   [ Time Frame: first 7 post operative days ]

4.  Secondary:   Decrease in Liver Lipid Peroxidation and Apoptosis   [ Time Frame: first 7 post operative days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Due to termination of the study no data analysis was performed.  


Results Point of Contact:  
Name/Title: Yuriy Gubenko, MD
Organization: UMDNJ
phone: 973 972-5007
e-mail: yuriygubenko@yahoo.com


No publications provided


Responsible Party: Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01031550     History of Changes
Other Study ID Numbers: 0120090226
Study First Received: December 10, 2009
Results First Received: September 16, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board