Lung NeoplasmsNCT01307085
Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
A study testing remote ischemic preconditioning in people with Lung Neoplasms, run by Cai Li at 1 site in China.
Trial summary
The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of pulmonary carcinoma
- Must be received pulmonary lobectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial
The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.
Read the 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.
- Conditions
- Lung Neoplasms
- Being tested
- remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, lung injury, pulmonary resection
- Medical subject headings
- Lung Neoplasms, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningProcedure or surgery
Also called RIP
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.
| Study group | Role | What they receive |
|---|---|---|
| preconditioning | Experimental | Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia. Receives: Procedure: remote ischemic preconditioning |
| conventional | No intervention | Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: June,2013
Secondary outcomes (2)
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)
Measured: June,2013
IL-6 and TNF-α
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).
Measured: June,2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cai Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xuan Ke Liu, Ph.d, Principal investigator, Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307085
- Sponsor's protocol ID
- RIP1126
- Status last verified
- Dec 2013
- First submitted
- 1 Mar 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01307085
- Acronym / sponsor ID
- RIP1126
- Conditions
- Lung Neoplasms
- Keywords
- remote ischemic preconditioning, lung injury, pulmonary resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Cai LiUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preconditioning | Experimental | Procedure: remote ischemic preconditioningAdult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia. |
| conventional | No intervention | –Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of pulmonary carcinoma
- Must be received pulmonary lobectomy
Key exclusion criteria (7 listed)
- 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℃)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic preconditioningAlso: RIPRemote 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. | Procedure or surgery | preconditioning |
Primary outcome
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)
2 secondary outcomes
Cs and Cd
Time frame: June,2013
IL-6 and TNF-α
Time frame: June,2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuan Ke Liu, Ph.d principal investigator
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning in people with Lung Neoplasms, run by Cai Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy (time frame: June,2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.