Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03681275

Enrollment

Registered

2018-09-24

Start date

2019-09-03

Completion date

2026-11-30

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Injury

Keywords

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.

Interventions

DRUGTofacitinib 10 MG [Xeljanz]

administered twice daily for two days

DRUGPlacebo to match Tofacitinib

administered twice daily for two days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition	5-6 years	Change in the force deficit that develops between the first and second muscle biopsies in the drug-treated vs. placebo groups

Secondary

Measure	Time frame	Description
Increase in muscle strength due to JAK inhibition	4-5 years	Difference in force generated by muscle biopsies taken at time point 1 (pre-mechanical ventilation) from the drug-treated vs placebo groups

Other

Measure	Time frame	Description
Exploratory: Determine mechanisms of changes in muscle strength and ventilator-induced diaphragm dysfunction by JAK inhibition.	4-6 years	Compare differences in muscle between the drug-treated and placebo groups in mitochondrial function and oxidative stress (ATP levels, citrate synthase activity, succinate dehydrogenase activity, mitochondrial respiration rate, activity of mitochondial enzymatic compexes).

Countries

United States

Contacts

Primary ContactCheyenne A Clinical Research Coordinator, B.S, M.S

csadeghi@stanford.edu3107201689

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026