Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diaphragm Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Tofacitinib

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

Group Type EXPERIMENTAL

Tofacitinib 10 MG [Xeljanz]

Intervention Type DRUG

administered twice daily for two days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo to match Tofacitinib

Intervention Type DRUG

administered twice daily for two days

Interventions

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Tofacitinib 10 MG [Xeljanz]

administered twice daily for two days

Intervention Type DRUG

Placebo to match Tofacitinib

administered twice daily for two days

Intervention Type DRUG

Other Intervention Names

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XELJANZ

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No