Acute Lung InjuryNCT02734654
Limb RIPC in Patients Undergoing Lung Lobectomy. Study of Oxidative Lung Damage
A study testing remote ischemic preconditioning (RIPC) in people with Acute Lung Injury, run by Instituto de Salud Carlos III.
Trial summary
Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after resection is associated to severe oxidative lung injury. The researchers hypothesized that remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the oxygenation parameters. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- remote ischemic preconditioning (RIPC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer patients (clinical stage I-II NSCLC)
- elective lung lobectomy
- patients were randomized and prospectively studied in a single centre
- all patients were ASA physical status I-II category
- pregnants
Who cannot join
- previous radiotherapy-chemotherapy
- previous thorax surgery
- PaO2 <60 mmHg
- FEV1 <50%
- cardiac disease (NYHA II-IV)
- active infections and temperature >37.5 ºC
About this study
Official title: Pulmonary Remote Preconditioning by Ischemia-reperfusion in Lung Lobectomy. A Study on the Prevention of Oxidative Stress
Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after resection is associated to severe oxidative lung injury. The researchers hypothesized that remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the oxygenation parameters.
Methods: We designed a single-centre, randomized, prospective and double-blind study, conducted in fifty-three patients with non-small cell lung cancer undergoing elective lung lobectomy.
Read more
Fifty-three patients were randomly assigned to 2 groups: 26 patients received limb RIPC (3 cycles: 5 min ischemia/5 min reperfusion induced by an ischemia cuff applied on the thigh) and 27 controls.
Time course of oxidative stress marker levels was simultaneously studied in exhaled breath condensate (EBC) and blood at four specific time points: T0, pre-operatively; T1, during operated lung collapse and one-lung ventilation (OLV); T2, immediately after resuming two-lung ventilation (TLV); T3, 120 min after resuming TLV.
EBC 8-isoprostane was the primary outcome. Secondary outcomes included PaO2/FiO2, other pulmonary oxygenation variables, other oxidative markers (NO2-+NO3-, H2O2) and pH.
Read the detailed description
In patients with non-small-cell lung carcinoma (NSCLC), the surgical resection remains the primary and preferred approach to the treatment of stage I-II NSCLC. Despite advances in surgical techniques, these patients have a risk of development a severe lung injury, because during lobectomy the operated lung is completely collapsed and hypoperfused. This hypoperfusion is due in part to a reactive hypoxic pulmonary vasoconstriction in response to alveolar hypoxia, which optimizes gas exchange. Hypoxic or ischemic tissues increase the reactive oxygen species (ROS) production in mitochondria respiratory chain, because the respiratory cytochromes become redox-reduced allowing them to directly transfer electrons to O2 producing large amount of superoxide anions, which contributes to more vasoconstriction. The primary site of ROS production during hypoxia appears to be complex III, and paradoxical increase of ROS production during hypoxia may be explained by an effect of O2 within mitochondria inner membrane on the ubisemiquinone radical in complex III. Thus, patients undergoing lobar resection suffer a relative lung ischemia-hypoxia during the collapse, followed by expansion-reperfusion injury attributed to the production of ROS. Acute lung injury (ALI) and postoperative adult respiratory distress syndrome (ARDS) after major thoracic surgery remains the leading cause of death from pulmonary surgery. Because to date few studies have assessed this subject in detail, we have showed recently also an increase of oxidative stress damage during lung lobectomy, associated to a direct correlation of lung collapse time with oxidative stress marker levels in exhaled breath condensate and blood.
Remote ischemic preconditioning (RIPC) has emerged as a procedure for different organs protection against acute ischemia/reperfusion injury as is shown by different clinical trials. Although most studies have been conducted in patients undergoing coronary artery by-pass grafting and valvular heart surgery, also were observed protective effect in other organs as kidneys, intestine and others. RIPC is an innate and powerful mechanism where a tissue or organ is exposed to a transient episode of ischemia-reperfusion and then confer a global resistance to subsequent episodes of ischemia in remote organs. However the potential mechanism through which RIPC works is unclear. The signal transfer to organs is through humoral, neuronal and systemic communications, which activate specific receptors, intracellular kinases and mitochondrial function. Recently has been reported that limb RIPC attenuates intestinal and pulmonary injury after abdominal aortic aneurysm repair and also after pulmonary resection, where they found significant decreases in serum malondialdehyde in treated group with RIPC.
EBC collection is non-invasive method for obtain samples from the lower respiratory tract, which contains large number of biomarkers including isoprostanes, nitrogen oxides and hydrogen peroxide. The isoprostanes are a family of products from arachidonic acid produced by the non-enzymatic action of ROS. Increased blood level of 8-isoprostane is considered a reliable index of lipid peroxidation in vivo due to its chemical stability. NO. and superoxide anion (O2.-) react to form ONOO-, which is a powerful oxidant. Nitrites (NO2-) and nitrates (NO3-) are end products of nitric oxide (NO.) and peroxynitrite anion (ONOO-) metabolism and present in the epithelial lining fluid of the respiratory tract. Hydrogen peroxide (H2O2) is a ROS and volatile molecule produced from conversion of superoxide anion (O2.-) to H2O2 by superoxide dismutase and released from inflammatory and epithelial cells of respiratory system.
The aim of this study is to investigate whether RIPC would reduce the oxidative lung injury in cancer patients undergoing lung lobectomy. The primary outcome of this study was compare 8-isoprostene and others oxidative marker levels in EBC and blood between patients receiving RIPC and control patients. Also to evaluate whether there is a correlation between OLV duration and oxidative stress marker levels in EBC and blood.
- Conditions
- Acute Lung Injury
- Being tested
- remote ischemic preconditioning (RIPC)
- Keywords
- oxidative stress, lung lobectomy
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioning (RIPC)Procedure or surgery
Remote ischemic preconditioning: The limb RIPC was applied after the induction of anaesthesia and consisted of 3 cycles: 5 min of ischemia by a cuff-inflator on a thigh and inflated to 200 mmHg, followed by 5 min deflated. The control group had during the same time a deflated cuff on a thigh.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | patients do not receive remote preconditioning prior to lung lobectomy |
| RIPC group | Experimental | patients receive remote preconditioning prior to lung lobectomy Receives: Procedure: remote ischemic preconditioning (RIPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course of 8-isoprostane levels in exhaled breath condensate during and after lung lobectomy
levels of 8-isoprostane in exhaled breath condensate were measured during lung lobectomy (T0: after anesthesia induction; T1: before two lung ventilation; T3: after two lung ventilation) and 2 hours after lobectomy in critical care unit (T3).
Measured: Approximately 4 hours: after anesthesia (T0), during lung lobectomy (T1, T2) and 2 hours after lung lobectomy (T3)
Secondary outcomes (1)
Time course of PO2/FiO2 ratio in arterial blood gas during and after lung lobectomy
PO2/FiO2 ratio in arterial blood gas during lung lobectomy and during 24 hours in critical care unit
Measured: during lung lobectomy (T0, T1, T2) and 24 hours after lung lobectomy in the critical care unit (T3, T4, T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startNov 2007
- Primary completionFeb 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Salud Carlos III
- Sponsor type
- Other government
- Responsible party
- Principal investigator, José García de la Asunción, Instituto de Salud Carlos III
- Investigators
- José García de la Asunción, MD, PhD, Principal investigator, Instituto de Investigador Sanitaria, INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734654
- Sponsor's protocol ID
- PI070836
- Status last verified
- Feb 2017
- First submitted
- 28 Mar 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-de-la-Asuncion J, Garcia-Del-Olmo E, Galan G, Guijarro R, Marti F, Badenes R, Perez-Griera J, Duca A, Delgado C, Carbonell J, Belda J. Glutathione oxidation correlates with one-lung ventilation time and PO2/FiO2 ratio during pulmonary lobectomy. Redox Rep. 2016 Sep;21(5):219-26. doi: 10.1080/13510002.2015.1101890. Epub 2016 Jan 21.
PubMed 26795138Misthos P, Katsaragakis S, Theodorou D, Milingos N, Skottis I. The degree of oxidative stress is associated with major adverse effects after lung resection: a prospective study. Eur J Cardiothorac Surg. 2006 Apr;29(4):591-5. doi: 10.1016/j.ejcts.2005.12.027. Epub 2006 Feb 14.
PubMed 16476542Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.
PubMed 16135737Przyklenk K, Whittaker P. Remote ischemic preconditioning: current knowledge, unresolved questions, and future priorities. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):255-9. doi: 10.1177/1074248411409040.
PubMed 21821525Garcia-de-la-Asuncion J, Garcia-del-Olmo E, Perez-Griera J, Marti F, Galan G, Morcillo A, Wins R, Guijarro R, Arnau A, Sarria B, Garcia-Raimundo M, Belda J. Oxidative lung injury correlates with one-lung ventilation time during pulmonary lobectomy: a study of exhaled breath condensate and blood. Eur J Cardiothorac Surg. 2015 Sep;48(3):e37-44. doi: 10.1093/ejcts/ezv207. Epub 2015 Jun 18.
PubMed 26088589
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Remote Preconditioning by Ischemia-reperfusion in Lung Lobectomy. A Study on the Prevention of Oxidative Stress
- ClinicalTrials.gov ID
- NCT02734654
- Acronym / sponsor ID
- PI070836
- Conditions
- Acute Lung Injury
- Keywords
- oxidative stress, lung lobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Instituto de Salud Carlos IIIOther government
- Study start
- Nov 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Apr 2016 (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.
Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after resection is associated to severe oxidative lung injury. The researchers hypothesized that remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the oxygenation parameters.
Methods: We designed a single-centre, randomized, prospective and double-blind study, conducted in fifty-three patients with non-small cell lung cancer undergoing elective lung lobectomy.
Fifty-three patients were randomly assigned to 2 groups: 26 patients received limb RIPC (3 cycles: 5 min ischemia/5 min reperfusion induced by an ischemia cuff applied on the thigh) and 27 controls.
Time course of oxidative stress marker levels was simultaneously studied in exhaled breath condensate (EBC) and blood at four specific time points: T0, pre-operatively; T1, during operated lung collapse and one-lung ventilation (OLV); T2, immediately after resuming two-lung ventilation (TLV); T3, 120 min after resuming TLV.
EBC 8-isoprostane was the primary outcome. Secondary outcomes included PaO2/FiO2, other pulmonary oxygenation variables, other oxidative markers (NO2-+NO3-, H2O2) and pH.
Detailed description
In patients with non-small-cell lung carcinoma (NSCLC), the surgical resection remains the primary and preferred approach to the treatment of stage I-II NSCLC. Despite advances in surgical techniques, these patients have a risk of development a severe lung injury, because during lobectomy the operated lung is completely collapsed and hypoperfused. This hypoperfusion is due in part to a reactive hypoxic pulmonary vasoconstriction in response to alveolar hypoxia, which optimizes gas exchange. Hypoxic or ischemic tissues increase the reactive oxygen species (ROS) production in mitochondria respiratory chain, because the respiratory cytochromes become redox-reduced allowing them to directly transfer electrons to O2 producing large amount of superoxide anions, which contributes to more vasoconstriction. The primary site of ROS production during hypoxia appears to be complex III, and paradoxical increase of ROS production during hypoxia may be explained by an effect of O2 within mitochondria inner membrane on the ubisemiquinone radical in complex III. Thus, patients undergoing lobar resection suffer a relative lung ischemia-hypoxia during the collapse, followed by expansion-reperfusion injury attributed to the production of ROS. Acute lung injury (ALI) and postoperative adult respiratory distress syndrome (ARDS) after major thoracic surgery remains the leading cause of death from pulmonary surgery. Because to date few studies have assessed this subject in detail, we have showed recently also an increase of oxidative stress damage during lung lobectomy, associated to a direct correlation of lung collapse time with oxidative stress marker levels in exhaled breath condensate and blood.
Remote ischemic preconditioning (RIPC) has emerged as a procedure for different organs protection against acute ischemia/reperfusion injury as is shown by different clinical trials. Although most studies have been conducted in patients undergoing coronary artery by-pass grafting and valvular heart surgery, also were observed protective effect in other organs as kidneys, intestine and others. RIPC is an innate and powerful mechanism where a tissue or organ is exposed to a transient episode of ischemia-reperfusion and then confer a global resistance to subsequent episodes of ischemia in remote organs. However the potential mechanism through which RIPC works is unclear. The signal transfer to organs is through humoral, neuronal and systemic communications, which activate specific receptors, intracellular kinases and mitochondrial function. Recently has been reported that limb RIPC attenuates intestinal and pulmonary injury after abdominal aortic aneurysm repair and also after pulmonary resection, where they found significant decreases in serum malondialdehyde in treated group with RIPC.
EBC collection is non-invasive method for obtain samples from the lower respiratory tract, which contains large number of biomarkers including isoprostanes, nitrogen oxides and hydrogen peroxide. The isoprostanes are a family of products from arachidonic acid produced by the non-enzymatic action of ROS. Increased blood level of 8-isoprostane is considered a reliable index of lipid peroxidation in vivo due to its chemical stability. NO. and superoxide anion (O2.-) react to form ONOO-, which is a powerful oxidant. Nitrites (NO2-) and nitrates (NO3-) are end products of nitric oxide (NO.) and peroxynitrite anion (ONOO-) metabolism and present in the epithelial lining fluid of the respiratory tract. Hydrogen peroxide (H2O2) is a ROS and volatile molecule produced from conversion of superoxide anion (O2.-) to H2O2 by superoxide dismutase and released from inflammatory and epithelial cells of respiratory system.
The aim of this study is to investigate whether RIPC would reduce the oxidative lung injury in cancer patients undergoing lung lobectomy. The primary outcome of this study was compare 8-isoprostene and others oxidative marker levels in EBC and blood between patients receiving RIPC and control patients. Also to evaluate whether there is a correlation between OLV duration and oxidative stress marker levels in EBC and blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –patients do not receive remote preconditioning prior to lung lobectomy |
| RIPC group | Experimental | Procedure: remote ischemic preconditioning (RIPC)patients receive remote preconditioning prior to lung lobectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- lung cancer patients (clinical stage I-II NSCLC)
- elective lung lobectomy
- patients were randomized and prospectively studied in a single centre
- all patients were ASA physical status I-II category
- pregnants
Key exclusion criteria (6 listed)
- previous radiotherapy-chemotherapy
- previous thorax surgery
- PaO2 <60 mmHg
- FEV1 <50%
- cardiac disease (NYHA II-IV)
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 preconditioning (RIPC)Remote ischemic preconditioning: The limb RIPC was applied after the induction of anaesthesia and consisted of 3 cycles: 5 min of ischemia by a cuff-inflator on a thigh and inflated to 200 mmHg, followed by 5 min deflated. The control group had during the same time a deflated cuff on a thigh. | Procedure or surgery | RIPC group |
Primary outcome
Time course of 8-isoprostane levels in exhaled breath condensate during and after lung lobectomy
Time frame: Approximately 4 hours: after anesthesia (T0), during lung lobectomy (T1, T2) and 2 hours after lung lobectomy (T3)
levels of 8-isoprostane in exhaled breath condensate were measured during lung lobectomy (T0: after anesthesia induction; T1: before two lung ventilation; T3: after two lung ventilation) and 2 hours after lobectomy in critical care unit (T3).
1 secondary outcome
Time course of PO2/FiO2 ratio in arterial blood gas during and after lung lobectomy
Time frame: during lung lobectomy (T0, T1, T2) and 24 hours after lung lobectomy in the critical care unit (T3, T4, T5)
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 3 Mar 2017.
- Background: PubMed 26795138Garcia-de-la-Asuncion J, Garcia-Del-Olmo E, Galan G, Guijarro R, Marti F, Badenes R, Perez-Griera J, Duca A, Delgado C, Carbonell J, Belda J. Glutathione oxidation correlates with one-lung ventilation time and PO2/FiO2 ratio during pulmonary lobectomy. Redox Rep. 2016 Sep;21(5):219-26. doi: 10.1080/13510002.2015.1101890. Epub 2016 Jan 21.
- Background: PubMed 16476542Misthos P, Katsaragakis S, Theodorou D, Milingos N, Skottis I. The degree of oxidative stress is associated with major adverse effects after lung resection: a prospective study. Eur J Cardiothorac Surg. 2006 Apr;29(4):591-5. doi: 10.1016/j.ejcts.2005.12.027. Epub 2006 Feb 14.
- Background: PubMed 16135737Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.
- Background: PubMed 21821525Przyklenk K, Whittaker P. Remote ischemic preconditioning: current knowledge, unresolved questions, and future priorities. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):255-9. doi: 10.1177/1074248411409040.
- Results publication: PubMed 26088589Garcia-de-la-Asuncion J, Garcia-del-Olmo E, Perez-Griera J, Marti F, Galan G, Morcillo A, Wins R, Guijarro R, Arnau A, Sarria B, Garcia-Raimundo M, Belda J. Oxidative lung injury correlates with one-lung ventilation time during pulmonary lobectomy: a study of exhaled breath condensate and blood. Eur J Cardiothorac Surg. 2015 Sep;48(3):e37-44. doi: 10.1093/ejcts/ezv207. Epub 2015 Jun 18.
- Individual participant dataSharing planned: No
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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.
José García de la Asunción, MD, PhD principal investigator
Instituto de Investigador Sanitaria, INCLIVA
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning (RIPC) in people with Acute Lung Injury, run by Instituto de Salud Carlos III.
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 5 inclusion and 6 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Time course of 8-isoprostane levels in exhaled breath condensate during and after lung lobectomy (time frame: Approximately 4 hours: after anesthesia (T0), during lung lobectomy (T1, T2) and 2 hours after lung lobectomy (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734654, which also lists 5 linked publications.
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 3 Mar 2017.