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Remote Ischemia Precondition (RIPC) for Hepatic Protection in Patients Undergoing Hepatectomy

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ClinicalTrials.gov Identifier: NCT02168608
Recruitment Status : Unknown
Verified June 2014 by Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date June 20, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
survival rate [ Time Frame: 30 days postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • alanine aminotransferase (ALT) level in patients' blood [ Time Frame: 1 day postoperatively ]
    Examine the patients's blood sample for ALT level at 1 day postoperatively
  • aspartic transaminase (AST) level in patients' blood [ Time Frame: 1 day postoperatively ]
    Examine the patients's blood sample for AST level at 1 day postoperatively
  • alanine aminotransferase (ALT) level in patients' blood [ Time Frame: 3 days postoperatively ]
    Examine the patients's blood sample for ALT level at 3 days postoperatively
  • aspartic transaminase (AST) level in patients' blood [ Time Frame: 3 days postoperatively ]
    Examine the patients's blood sample for AST level at 3 days postoperatively
  • alanine aminotransferase (ALT) level in patients' blood [ Time Frame: 7 days postoperatively ]
    Examine the patients's blood sample for ALT level at 7 days postoperatively
  • aspartic transaminase (AST) level in patients' blood [ Time Frame: 7 days postoperatively ]
    Examine the patients's blood sample for AST level at 7 days postoperatively
  • complications [ Time Frame: 30 days postoperatively ]
    Number of participants with adverse events within 30 days postoperatively
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Ischemia Precondition (RIPC) for Hepatic Protection in Patients Undergoing Hepatectomy
Official Title  ICMJE Remote Ischemia Precondition for Hepatic Protection in Patients Undergoing Hepatectomy: A Single-center Randomized Controlled Trial
Brief Summary Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.
Detailed Description Remote ischemia precondition (RIPC) had been proofed beneficial to ischemia reperfusion injury of heart, kidney, liver, brain and spinal cord in experimentation on animals. And the clinical studies of RIPC were mainly focused on heart, RIPC's protection effect on hepatic ischemia reperfusion injury in patients undergoing hepatectomy still remains unknown, So we designed this study to demonstrate the hypotheses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Liver Neoplasms
Intervention  ICMJE
  • Other: Remote ischemia precondition
    Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the right upper arm served as RIPC stimulus.
  • Other: None remote ischemia precondition
    Placed an uninflated cuff on the right upper arm for 30 min.
Study Arms  ICMJE
  • Experimental: Remote ischemia precondition
    patients in this arm accepted RIPC procedure after induction of anesthesia
    Intervention: Other: Remote ischemia precondition
  • Experimental: None remote ischemia precondition
    patients in this arm didn't accept RIPC procedure after induction of anesthesia
    Intervention: Other: None remote ischemia precondition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade
  • Selective hepatectomy, one time hepatic portal occlusion
  • Child-Pugh A

Exclusion Criteria:

  • Peripheral vessels diseases
  • Not the same surgical procedure as expected
  • Administered anti-inflammatory drugs as glucocorticoid etc
  • Diagnosed of diabetes
  • History of liver surgery
  • History of hepatic interventional therapy, radiofrequency therapy,radiotherapy and chemotherapy
  • Refuse to join the research
  • Patients with psychopathy
  • Acute infection need antibiotic therapy
  • Hepatic artery or portal vein embolism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168608
Other Study ID Numbers  ICMJE EHBHKY2013-003-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital
Study Sponsor  ICMJE Eastern Hepatobiliary Surgery Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Weifeng Yu, professor Eastern Hepatobiliary Surgery Hospital
PRS Account Eastern Hepatobiliary Surgery Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP