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Completed

NCT Number: NCT01307085

Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischemic preconditioning

Procedure

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 names: RIP

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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).

Sponsors and collaborators

Lead sponsor

Cai Li

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2011
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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