Blocking specific molecules to prevent diaphragm injury in patients on ventilators
A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
PHASE2 · Stanford University · NCT03681275
This study is testing if a medication called tofacitinib can help prevent diaphragm problems in patients on ventilators after surgery for esophagus issues.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT03681275 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of tofacitinib, a Janus kinase inhibitor, in preventing ventilator-induced diaphragm dysfunction (VIDD) in patients undergoing esophagectomy. By targeting the molecular mechanisms associated with diaphragm injury, the researchers hope to demonstrate that this intervention can mitigate the development of VIDD in humans, similar to previous animal studies. The study will compare the effects of tofacitinib against a placebo to assess its efficacy in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for esophagectomy who do not have significant pulmonary dysfunction or neuromuscular diseases.
Not a fit: Patients with severe pulmonary dysfunction, neuromuscular diseases, or those on immunosuppressant medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce diaphragm injury in patients on mechanical ventilation, improving their recovery and overall outcomes.
How similar studies have performed: Previous studies have shown promising results in animal models regarding the prevention of VIDD through similar molecular interventions, but this approach in humans is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stanford, California
- Stanford University Medical Center — Stanford, California, United States (RECRUITING)
Study contacts
- Principal investigator: Joseph Shrager, MD — Stanford University
- Study coordinator: Cheyenne A Clinical Research Coordinator, B.S, M.S
- Email: csadeghi@stanford.edu
- Phone: 3107201689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diaphragm Injury, Ventilator-induced Diaphragm Dysfunction