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Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

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.
 
ClinicalTrials.gov Identifier: NCT01307085
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Cai Li, First Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE March 1, 2011
First Posted Date  ICMJE March 2, 2011
Last Update Posted Date December 12, 2013
Study Start Date  ICMJE February 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy [ Time Frame: June,2013 ]
PaO2/FiO2 in the limb RIPC group was significantly higher than that in the control group at 30 and 60 min after OLV, 30 min and 6 h after operation (all P<0.05)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • Cs and Cd [ Time Frame: June,2013 ]
    Cs and Cd in limb RIPC group were significantly higher than those in the control group at 30 and 60 min after OLV (all P<0.05)
  • IL-6 and TNF-α [ Time Frame: June,2013 ]
    The IL-6 levels in the limb RIPC group were lower than those in the control group at 30 min, 6, 12, 24 and 48 h after operation (all P<0.05), and there was a significant difference in TNF-α level between the groups (P<0.01).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
Official Title  ICMJE Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial
Brief Summary The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.
Detailed Description Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. It is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. The investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE Procedure: remote ischemic preconditioning
Remote ischaemic preconditioning consisted of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other Name: RIP
Study Arms  ICMJE
  • Experimental: preconditioning
    Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.
    Intervention: Procedure: remote ischemic preconditioning
  • No Intervention: conventional
    Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2013)
108
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2011)
60
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of pulmonary carcinoma
  • Must be received pulmonary lobectomy

Exclusion Criteria:

  • Cardiac disease categorized as NYHA classes II-IV
  • Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted),
  • Pre-existing coagulopathy or thrombocytopenia
  • Prior receipt of chemotherapy or radiation therapy or immunotherapy
  • Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38℃)
  • Peripheral vascular disease affecting the upper limbs
  • Administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 NCT01307085
Other Study ID Numbers  ICMJE RIP1126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cai Li, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Cai Li
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xuan Ke Liu, Ph.d Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date December 2013

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