Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Diaphragm Injury

Treatments: Drug: Placebo to match Tofacitinib; Drug: Tofacitinib 10 MG [Xeljanz]

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03681275

3R01AG069858-02W1 (Other Grant/Funding Number)

IRB-47826

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Tofacitinib

Experimental group

Description:

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

Treatment:

Drug: Tofacitinib 10 MG [Xeljanz]

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to match Tofacitinib