Inflammatory Lung InjuryPhase 1/2APLICSNCT02918877
Anesthetics to Prevent Lung Injury in Cardiac Surgery
A Phase 1/2 study testing Sevoflurane and Propofol in people with Inflammatory Lung Injury and Ischemia-Reperfusion Lung Injury, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury, Postoperative Pulmonary Complications
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 1 Feb 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18+)
- Undergoing cardiac surgery with cardiopulmonary bypass
Who cannot join
- Emergency surgery
- History of severe COPD, emphysema, or ILD
- Recent (<2wk) or current use of systemic glucocorticoids
- Prior history of pneumothorax
- Allergy/contraindication to intravenous anesthetics
- Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.
Read the detailed description
Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.
- Conditions
- Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury, Postoperative Pulmonary Complications
- Being tested
- Sevoflurane, Propofol
- Keywords
- Volatile Anesthetics, Intravenous Anesthetics, Inflammatory Lung Injury, Postoperative Pulmonary Complications, Cardiac Surgery, Cardiopulmonary Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Volatile Anesthetic
PropofolDrug
Also called Diprivan
Intravenous Anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Anesthesia | Experimental | Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. Receives: Drug: Sevoflurane |
| Intravenous Anesthesia | Active comparator | Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
Measured: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary outcomes (6)
Number of Patients With Postoperative Pulmonary Complications
Composite endpoint of clinically relevant pulmonary complications
Measured: Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up.
BAL Concentration of IL1b (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
Measured: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of IL6 (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
Measured: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of IL8 (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
Measured: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of MCP1 (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
Measured: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of sRAGE (pg/mL)
Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)
Measured: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start9 Jun 2017
- Primary completion24 Dec 2018
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Lung InjuryStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian O'Gara, Beth Israel Deaconess Medical Center
- Investigators
- Brian O'Gara, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918877
- Sponsor's protocol ID
- 2016P000306
- Acronym
- APLICS
- Status last verified
- Apr 2021
- First submitted
- 30 Aug 2016
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Gara B, Subramaniam B, Shaefi S, Mueller A, Banner-Goodspeed V, Talmor D. Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial. Trials. 2019 May 31;20(1):312. doi: 10.1186/s13063-019-3400-x.
PubMed 31151474
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetics to Prevent Lung Injury in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02918877
- Acronym / sponsor ID
- APLICS / 2016P000306
- Conditions
- Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury, Postoperative Pulmonary Complications
- Keywords
- Volatile Anesthetics, Intravenous Anesthetics, Inflammatory Lung Injury, Postoperative Pulmonary Complications, Cardiac Surgery, Cardiopulmonary Bypass
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 5 May 2021
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 investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.
Detailed description
Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Anesthesia | Experimental | Drug: SevofluranePatients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. |
| Intravenous Anesthesia | Active comparator | Drug: PropofolPatients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age 18+)
- Undergoing cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (6 listed)
- Emergency surgery
- History of severe COPD, emphysema, or ILD
- Recent (<2wk) or current use of systemic glucocorticoids
- Prior history of pneumothorax
- Allergy/contraindication to intravenous anesthetics
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 |
|---|---|---|
| SevofluraneVolatile Anesthetic | Drug | Inhaled Anesthesia |
| PropofolAlso: DiprivanIntravenous Anesthetic | Drug | Intravenous Anesthesia |
Primary outcome
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
6 secondary outcomes
Number of Patients With Postoperative Pulmonary Complications
Time frame: Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up.
BAL Concentration of IL1b (pg/mL)
Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of IL6 (pg/mL)
Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of IL8 (pg/mL)
Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of MCP1 (pg/mL)
Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of sRAGE (pg/mL)
Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31151474O'Gara B, Subramaniam B, Shaefi S, Mueller A, Banner-Goodspeed V, Talmor D. Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial. Trials. 2019 May 31;20(1):312. doi: 10.1186/s13063-019-3400-x.
- 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.
Brian O'Gara, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sevoflurane and Propofol in people with Inflammatory Lung Injury and Ischemia-Reperfusion Lung Injury, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 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 5 May 2021. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) (time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass). 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 NCT02918877, which also lists 1 linked publication.
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 5 May 2021.