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JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03681275
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
45.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tofacitinib 5 mg
  • Drug: Placebo to match Tofacitinib
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
Actual Study Start Date :
Sep 3, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tofacitinib

Patient will receive two days treatment with tofacitinib prior to the surgery.

Drug: Tofacitinib 5 mg
administered twice daily for two days
Other Names:
  • XELJANZ

    		•
    Placebo Comparator: Placebo

    Patient will receive two days treatment with placebo prior to the surgery.

    Drug: Placebo to match Tofacitinib
    administered twice daily for two days

    Outcome Measures

    Primary Outcome Measures

    1. Count of participants with JAK/STAT pathway activation as a result of tofacitinib treatment [up to 1 year]

      A participant will be included if activation is detected through gene expression, protein expression, phosphorylation levels, and/or cytokine levels.

    Secondary Outcome Measures

    1. Count of Participant with Ventilator-induced Diaphragm Dysfunction. [up to 1 year]

      Compare treatment arm to placebo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing esophagectomy
    Exclusion Criteria:

    • Patients with more than mild pulmonary dysfunction

    • Patients with any neuromuscular disease that might compromise diaphragm function

    • Patients with abnormal liver or kidney function

    • Patients taking any immunosuppressant medication (including prednisone) or antifungal medications

    • History of tuberculosis

    • Weight loss of >5% of body weight over previous 6 months

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Medical Center Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Joseph Shrager, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joseph B. Shrager, Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03681275
    Other Study ID Numbers:
    • IRB-47826
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    May 26, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Joseph B. Shrager, Professor, Stanford University
    Ventilator-induced Diaphragm Dysfunction
    Additional relevant MeSH terms:
    Tofacitinib

    Study Results

    No Results Posted as of May 26, 2021