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NCT Number: NCT03681275

Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

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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Key information

Conditions

Diaphragm Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Study Team

CONTACT

[email protected]

650-721-6561

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tofacitinib 10 MG [Xeljanz]

Drug

administered twice daily for two days

Other names: XELJANZ

Placebo to match Tofacitinib

Drug

administered twice daily for two days

Primary outcomes

  1. Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition

    Time frame: 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 outcomes

  1. Increase in muscle strength due to JAK inhibition

    Time frame: 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 outcomes

  1. Exploratory: Determine mechanisms of changes in muscle strength and ventilator-induced diaphragm dysfunction by JAK inhibition.

    Time frame: 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).

  2. Exploratory: Determine mechanisms of changes in muscle strength and ventilator-induced diaphragm dysfunction by JAK inhibition.

    Time frame: 4-6 years

    Compare differences in muscle between the drug-treated and placebo groups in proteolytic pathways (quantitative PCR for atrogein, MuRF1, and FoxO gene expression, western blot analysis for protein levels of these and protein polyubiquitination, proteasomal activity, qPCR and western blots for expression of LC3).

  3. Exploratory: Determine mechanisms of changes in muscle strength and ventilator-induced diaphragm dysfunction by JAK inhibition.

    Time frame: 4-6 years

    Compare differences in muscle between the drug-treated and placebo groups in transcriptomic gene profiling, and metabolomic profiling..

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

3107201689

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2018
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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