Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Phase 2RecruitingNCT03681275

Stanford University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Diaphragm Injury

Interventions

Tofacitinib 10 MG [Xeljanz]DRUG

administered twice daily for two days

Placebo to match TofacitinibDRUG

administered twice daily for two days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University Medical Center

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition

Change in the force deficit that develops between the first and second muscle biopsies in the drug-treated vs. placebo groups

Time frame: 5-6 years

Secondary Outcomes

Increase in muscle strength due to JAK inhibition

Difference in force generated by muscle biopsies taken at time point 1 (pre-mechanical ventilation) from the drug-treated vs placebo groups

Time frame: 4-5 years

Central Contacts

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

CONTACT

3107201689 csadeghi@stanford.edu

Data from ClinicalTrials.gov

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