Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Phase 2

Recruiting

• Conditions: Diaphragm Injury
• Interventions: Drug: Tofacitinib 10 MG [Xeljanz]; Drug: Placebo to match Tofacitinib

• Registration Number: NCT03681275
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2019-09-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients undergoing esophagectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tofacitinib	Tofacitinib 10 MG [Xeljanz]	Patient will receive two days treatment with tofacitinib prior to the surgery.
Placebo	Placebo to match Tofacitinib	Patient will receive two days treatment with placebo prior to the surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States