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JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681275
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph B. Shrager, Stanford University

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
Diaphragm Injury Drug: Tofacitinib 5 mg Drug: Placebo to match Tofacitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 3, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Count of participants with JAK/STAT pathway activation as a result of tofacitinib treatment [ Time Frame: 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. [ Time Frame: up to 1 year ]
    Compare treatment arm to placebo



Information from the National Library of Medicine

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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:

  • 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

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): NCT03681275


Locations
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United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Study Team    650-721-6561    snesbit@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Joseph Shrager, MD Stanford University
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Responsible Party: Joseph B. Shrager, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03681275    
Other Study ID Numbers: IRB-47826
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.

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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 Joseph B. Shrager, Stanford University:
Ventilator-induced Diaphragm Dysfunction
Additional relevant MeSH terms:
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Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action