Recruiting
Phase 2

Janus Kinase Inhibition

Sponsor:

Stanford University

Code:

NCT03681275

Conditions

Diaphragm Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tofacitinib 10 MG [Xeljanz]

Placebo to match Tofacitinib

Study Details

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.

Conditions

Diaphragm Injury

Study ID

NCT03681275

Start date

Sep 3, 2019

Status verified date

Nov, 2024

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tofacitinib

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

placebo comparator: Placebo

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

Interventions

Tofacitinib 10 MG [Xeljanz]

administered twice daily for two days

Placebo to match Tofacitinib

administered twice daily for two days

Primary outcome measure

  • Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition [ Time Frame: 5-6 years ]

Central Contacts and Locations

Central contacts

Cheyenne A Clinical Research Coordinator, B.S, M.S

3107201689csadeghi@stanford.edu

Locations

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Study Team

650-721-6561csadeghi@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • Ventilator-induced Diaphragm Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-11-25.