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Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS)

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ClinicalTrials.gov Identifier: NCT02918877
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Brian O'Gara, Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammatory Lung Injury Ischemia-Reperfusion Lung Injury Postoperative Pulmonary Complications Drug: Sevoflurane Drug: Propofol Phase 1 Phase 2

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anesthetics to Prevent Lung Injury in Cardiac Surgery
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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
Volatile Anesthetic

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
Intravenous Anesthetic
Other Name: Diprivan




Primary Outcome Measures :
  1. Bronchoalveolar Lavage (BAL) Concentration of TNF alpha (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Inflammatory mediator found in BAL fluid during lung inflammation


Secondary Outcome Measures :
  1. 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. ]
    Composite endpoint of clinically relevant pulmonary complications

  2. BAL concentration of IL1b (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Inflammatory mediator found in BAL fluid during lung inflammation

  3. BAL concentration of IL6 (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Inflammatory mediator found in BAL fluid during lung inflammation

  4. BAL concentration of IL8 (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Inflammatory mediator found in BAL fluid during lung inflammation

  5. BAL concentration of MCP1 (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Inflammatory mediator found in BAL fluid during lung inflammation

  6. BAL concentration of sRAGE (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Biomarker of lung injury

  7. BAL concentration of angiopoietin 2 (ng/L) [ Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass ]
    Biomarker of lung injury



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918877


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Brian O'Gara, MD Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian O'Gara, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02918877    
Other Study ID Numbers: 2016P000306
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brian O'Gara, Beth Israel Deaconess Medical Center:
Volatile Anesthetics
Intravenous Anesthetics
Inflammatory Lung Injury
Postoperative Pulmonary Complications
Cardiac Surgery
Cardiopulmonary Bypass
Additional relevant MeSH terms:
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Lung Injury
Ischemia
Wounds and Injuries
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation