NCT02918877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 5, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

August 30, 2016

Results QC Date

February 16, 2021

Last Update Submit

April 12, 2021

Conditions

Inflammatory Lung InjuryIschemia-Reperfusion Lung InjuryPostoperative Pulmonary Complications

Keywords

Volatile AnestheticsIntravenous AnestheticsInflammatory Lung InjuryPostoperative Pulmonary ComplicationsCardiac SurgeryCardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

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

    Inflammatory mediator found in BAL fluid during lung inflammation

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

Secondary Outcomes (6)

  • Number of Patients With Postoperative Pulmonary Complications

    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)

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

  • BAL Concentration of IL6 (pg/mL)

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

  • BAL Concentration of IL8 (pg/mL)

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

  • BAL Concentration of MCP1 (pg/mL)

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

  • +1 more secondary outcomes

Study Arms (2)

Inhaled Anesthesia

EXPERIMENTAL

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

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.

Drug: Propofol

Interventions

SevofluraneDRUG

Volatile Anesthetic

Inhaled Anesthesia
PropofolDRUG

Intravenous Anesthetic

Also known as: Diprivan
Intravenous Anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 31151474DERIVED

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Dr. Brian P. O'Gara
Organization
Beth Israel Deaconess Medical Center
bpogara@bidmc.harvard.edu
617-549-2974

Study Officials

  • Brian O'Gara, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 29, 2016

Study Start

June 9, 2017

Primary Completion

December 24, 2018

Study Completion

February 1, 2021

Last Updated

May 5, 2021

Results First Posted

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)