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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

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE September 24, 2018
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE September 3, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Count of Participant with Ventilator-induced Diaphragm Dysfunction. [ Time Frame: up to 1 year ]
Compare treatment arm to placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
Count of Participant with Ventilator-induced Diaphragm Dysfunction. [ Time Frame: up to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
Official Title  ICMJE A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Diaphragm Injury
Intervention  ICMJE
  • Drug: Tofacitinib 5 mg
    administered twice daily for two days
    Other Name: XELJANZ
  • Drug: Placebo to match Tofacitinib
    administered twice daily for two days
Study Arms  ICMJE
  • Experimental: Tofacitinib
    Patient will receive two days treatment with tofacitinib prior to the surgery.
    Intervention: Drug: Tofacitinib 5 mg
  • Placebo Comparator: Placebo
    Patient will receive two days treatment with placebo prior to the surgery.
    Intervention: Drug: Placebo to match Tofacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2018)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03681275
Other Study ID Numbers  ICMJE IRB-47826
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD.
Responsible Party Joseph B. Shrager, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Shrager, MD Stanford University
PRS Account Stanford University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP