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

Study Description

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.

Study Design

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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

Drug Information available for: Propofol Sevoflurane

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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

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