Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

Lung Neoplasms Clinical Trial

Official title:

Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307085
• Other study ID #: RIP1126
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: December 11, 2013
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Injury
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Cai Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy	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)	June,2013	Yes
Secondary	Cs and Cd	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)	June,2013	Yes
Secondary	IL-6 and TNF-a	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-a level between the groups (P<0.01).	June,2013	Yes