Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Purpose

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

  • Diaphragm Injury

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tofacitinib 		Patient will receive two days treatment with tofacitinib prior to the surgery.
  • Drug: Tofacitinib 10 MG [Xeljanz]
    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

Recruiting Locations

Stanford University Medical Center
Stanford, California 94305
Contact:
Study Team
650-721-6561
csadeghi@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Cheyenne A Clinical Research Coordinator, B.S, M.S
3107201689
csadeghi@stanford.edu