Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cai Li, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01307085
First received: March 1, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.


Condition Intervention
Lung Neoplasms
Procedure: remote ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy [ Time Frame: June,2013 ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Cs and Cd [ Time Frame: June,2013 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 108
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preconditioning
Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.
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
No Intervention: conventional
Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307085

Locations
China, Guangdong
Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Cai Li
Investigators
Principal Investigator: Xuan Ke Liu, Ph.d Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Cai Li, Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01307085     History of Changes
Other Study ID Numbers: RIP1126
Study First Received: March 1, 2011
Last Updated: December 11, 2013
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
remote ischemic preconditioning
lung injury
pulmonary resection

Additional relevant MeSH terms:
Lung Injury
Lung Neoplasms
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014