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CompletedNCT02918877APLICSUpdated May 5, 2021Results posted

Anesthetics to Prevent Lung Injury in Cardiac Surgery

A Phase 1/2 interventional study of Sevoflurane and Propofol in Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury and Postoperative Pulmonary Complications, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.

Sponsored by Beth Israel Deaconess Medical Center · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • 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
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In context

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's enrollment of 51 is close to the median of 53 across 239 interventional studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients (age 18+)
  • Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Inhaled Anesthesia

    Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.

    Drug: Sevoflurane

  • Active comparator
    Intravenous Anesthesia

    Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.

    Drug: Propofol

Interventions

  • DrugSevoflurane

    Volatile Anesthetic

  • DrugPropofol

    Intravenous Anesthetic

    Also known as: Diprivan

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What researchers measure

Primary outcomes

  1. Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)

    Inflammatory mediator found in BAL fluid during lung inflammation

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Secondary outcomes

  1. Number of Patients With Postoperative Pulmonary Complications

    Composite endpoint of clinically relevant 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.

  2. BAL Concentration of IL1b (pg/mL)

    Inflammatory mediator found in BAL fluid during lung inflammation

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

  3. BAL Concentration of IL6 (pg/mL)

    Inflammatory mediator found in BAL fluid during lung inflammation

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

  4. BAL Concentration of IL8 (pg/mL)

    Inflammatory mediator found in BAL fluid during lung inflammation

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

  5. BAL Concentration of MCP1 (pg/mL)

    Inflammatory mediator found in BAL fluid during lung inflammation

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

  6. BAL Concentration of sRAGE (pg/mL)

    Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

07

Results

Posted May 5, 2021

Participant flow

51 Enrolled

Participant flow — Overall Study
MilestoneInhaled AnesthesiaIntravenous Anesthesia
Started2425
Completed1822
Not completed63
Withdrew: Withdrawal by subject22
Withdrew: Surgery cancelled10
Withdrew: Physician decision10
Withdrew: Received intraoperative steroids10
Withdrew: Unable to obtain lab samples10
Withdrew: Unsafe to perform bal01

Outcome measures

PrimaryBronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

Time frame:
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Reported as:
Median · pg/mL
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
pg/mLInhaled AnesthesiaIntravenous Anesthesia
Pre-Bypass0.53 (0.53 to 4.99)0.53 (0.53 to 13.80)
Post-Bypass22.06 (1.75 to 623.08)102.04 (2.21 to 408.05)
Difference17.24 (1.22 to 536.77)101.51 (1.47 to 402.84)
SecondaryNumber of Patients With Postoperative Pulmonary Complications

Composite endpoint of clinically relevant 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.
Reported as:
Count of participants · Participants
Number of Patients With Postoperative Pulmonary Complications
ParticipantsInhaled AnesthesiaIntravenous Anesthesia
Prolonged intubation (greater than 48hrs)03
Failed extubation (re-intubated within 24hrs)01
Reintubation (greater than 24hrs after extubation)02
Pulmonary edema48
Pleural effusion1721
Atelectasis1619
Infiltrate/consolidation66
Pneumothorax15
ARDS00
Pneumonia01
Brochospasm11
Exacerbation of chronic lung disease00
Hypoxia (PaO2/FiO2 < 300)1615
Respiratory acidosis (PaCO2 > 45)1215
Any postoperative pulmonary complication1822
SecondaryBAL Concentration of IL1b (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

Time frame:
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Reported as:
Median · pg/mL
BAL Concentration of IL1b (pg/mL)
pg/mLInhaled AnesthesiaIntravenous Anesthesia
Pre-Bypass0.42 (0.06 to 2.61)0.87 (0.28 to 2.54)
Post-Bypass8.56 (0.21 to 64.77)14.37 (1.88 to 76.10)
Difference8.30 (-0.67 to 59.64)11.00 (1.18 to 66.14)
SecondaryBAL Concentration of IL6 (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

Time frame:
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Reported as:
Median · pg/mL
BAL Concentration of IL6 (pg/mL)
pg/mLInhaled AnesthesiaIntravenous Anesthesia
Pre-Bypass30.70 (6.77 to 96.60)31.35 (5.27 to 165.93)
Post-Bypass275.19 (6.21 to 1134.33)297.35 (40.59 to 1277.04)
Difference220.68 (-12.41 to 1046.00)259.32 (30.33 to 1039.58)
SecondaryBAL Concentration of IL8 (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

Time frame:
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Reported as:
Median · pg/mL
BAL Concentration of IL8 (pg/mL)
pg/mLInhaled AnesthesiaIntravenous Anesthesia
Pre-Bypass2008.50 (341.25 to 16444.75)6528.50 (625.00 to 16332.25)
Post-Bypass8019.50 (998.25 to 100438.00)27789.50 (4780.50 to 154087.75)
Difference4701.00 (-290.25 to 77061.00)16230.00 (1399.25 to 123098.50)
SecondaryBAL Concentration of MCP1 (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

Time frame:
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Reported as:
Median · pg/mL
BAL Concentration of MCP1 (pg/mL)
pg/mLInhaled AnesthesiaIntravenous Anesthesia
Pre-Bypass509.50 (249.25 to 1415.75)977.50 (336.50 to 1225.75)
Post-Bypass496.00 (184.25 to 2153.25)883.50 (651.50 to 4380.50)
Difference148.00 (-265.75 to 869.75)479.50 (-104.25 to 1482.75)
SecondaryBAL Concentration of sRAGE (pg/mL)

Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)

Time frame:
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Reported as:
Median · pg/mL
BAL Concentration of sRAGE (pg/mL)
pg/mLInhaled AnesthesiaIntravenous Anesthesia
Pre-Bypass156.50 (44.00 to 383.00)164 (60.75 to 380.50)
Post-Bypass597.00 (220.50 to 1195.00)465.00 (206.00 to 2120.50)
Difference402.50 (155.25 to 1063.25)224.50 (-69.25 to 2088.25)

Adverse events

Collected over During hospital length of stay ~7 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Inhaled Anesthesia0/18 (0%)0/18 (0%)18/18 (100%)
Intravenous Anesthesia1/22 (4.5%)0/22 (0%)22/22 (100%)
Most frequent other events
Showing 10 of 12
Most frequent other events
EventInhaled AnesthesiaIntravenous Anesthesia
Pleural effusionRespiratory, thoracic and mediastinal disorders17/1821/22
AtelectasisRespiratory, thoracic and mediastinal disorders16/1819/22
Hypoxia (PaO2/FiO2 < 300)Respiratory, thoracic and mediastinal disorders16/1815/22
Respiratory acidosis (PaCO2 > 45)Respiratory, thoracic and mediastinal disorders12/1815/22
Pulmonary edemaRespiratory, thoracic and mediastinal disorders4/188/22
Infiltrate/consolidationRespiratory, thoracic and mediastinal disorders6/186/22
PneumothoraxRespiratory, thoracic and mediastinal disorders1/185/22
Prolonged intubation (greater than 48hrs)Respiratory, thoracic and mediastinal disorders0/183/22
Reintubation (greater than 24hrs after extubation)Respiratory, thoracic and mediastinal disorders0/182/22
BrochospasmRespiratory, thoracic and mediastinal disorders1/181/22

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Mean61.3 ± 10.164.6 ± 10.962.9 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Female257
Male161733
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Race — White161531
Race — Black/African American011
Race — Hispanic or Latino235
Race — Unknown033
Weight
Weight(Pounds)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Mean207.82 ± 39.60194.10 ± 42.54200.96 ± 41.07
Height
Height(Inches)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Mean69.11 ± 3.6568.41 ± 3.4968.76 ± 3.57
Body Mass Index
Body Mass Index(kg/m^2)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Mean31.20 ± 4.3429.61 ± 5.0230.41 ± 4.68
Comorbidities
Comorbidities(Participants)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Hypertension151833
Hyperlipidemia151429
Congestive Heart Failure314
Arrhythmia134
Obesity639
Chronic Obstructive Pulmonary Disease/Asthma224
Diabetes without Complications145
Diabetes with End Organ Damage358
Moderate or Severe Renal Disease303
Solid (Non-Metastatic) Tumor325
ASA Score (American Society of Anesthesiologists)
ASA Score (American Society of Anesthesiologists)(scores on a scale.)Inhaled AnesthesiaIntravenous AnesthesiaTotal
Mean3.67 ± 0.483.82 ± 0.393.75 ± 0.44

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
09

References and documents

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 documents

  • Protocol and statistical analysis plan · Aug 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02918877
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Brian O'Gara (MD, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Sep 29, 2016
Start date
Jun 9, 2017
Primary completion
Dec 24, 2018
Completion
Feb 1, 2021
Results posted
May 5, 2021
Last update
May 5, 2021

Study contacts

Brian O'Gara, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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