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Isoflurane Preconditioning for Liver Resections

This study has been terminated.
(We no longer had an appropriate patient population.Study closed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01031550
First Posted: December 14, 2009
Last Update Posted: March 20, 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):
Yuriy Gubenko, MD, Rutgers, The State University of New Jersey
Results First Submitted: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Liver Disease
Interventions: Drug: isoflurane
Drug: propofol

  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 propofol 100-150mcg/kg/min
Preconditioning With 2 MAC Isoflurane Group preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).

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 with propofol 100-150mcg/kg/min
Preconditioning With 2 MAC Isoflurane Group preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
Total Total of all reporting groups

Baseline Measures
   Standard Anesthetic Management   Preconditioning With 2 MAC Isoflurane Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   3   8 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      4  80.0%      3 100.0%      7  87.5% 
>=65 years      1  20.0%      0   0.0%      1  12.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 40  (10)   38  (8)   39  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  40.0%      1  33.3%      3  37.5% 
Male      3  60.0%      2  66.7%      5  62.5% 
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 Which is a Classification System Used to Grade Surgical Complications   [ 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


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


  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: Yuriy Gubenko, MD
Organization: UMDNJ
phone: 973 972-5007
e-mail: yuriygubenko@yahoo.com



Responsible Party: Yuriy Gubenko, MD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01031550     History of Changes
Other Study ID Numbers: 0120090226
First Submitted: December 10, 2009
First Posted: December 14, 2009
Results First Submitted: September 16, 2013
Results First Posted: December 12, 2013
Last Update Posted: March 20, 2017