Monitoring muscle mass changes in critically ill patients
Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
NA · University Hospital Ostrava · NCT04758676
This study is testing if a special nutrition and physiotherapy plan can help critically ill patients on ventilators recover better and improve their muscle mass compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava (other) |
| Locations | 2 sites (Ostrava, Moravian-Silesian Region and 1 other locations) |
| Trial ID | NCT04758676 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate changes in body composition, particularly muscle mass, in critically ill patients undergoing artificial ventilation for at least seven days. It will compare the effects of a nutritional and physiotherapy protocol against standard care on patients' recovery and quality of life over a 12-week period. The focus is on understanding and mitigating the long-term consequences of post-intensive care syndrome (PICS), which can severely impact physical, cognitive, and mental health. The study will utilize bioelectric impedance analysis (BIA) to monitor these changes.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients with respiratory insufficiency who are expected to require artificial ventilation for at least seven days.
Not a fit: Patients with a poor prognosis for 12-week follow-up or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery outcomes and quality of life for critically ill patients post-ICU.
How similar studies have performed: Other studies have shown promise in improving outcomes for critically ill patients through nutritional and rehabilitation interventions, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with respiratory insufficiency * Expected period of artificial ventilation of 7 days * Acute lung injury (ALI) * Acute respiratory distress syndrome (ARDS) * Acute exacerbation of chronic obstructive pulmonary disease (COPD) * Signed informed consent (may be signed by witnesses, if the patient is unconscious) Exclusion Criteria: * Patients with unfavorable prognosis for 12-week follow-up * APACHE Score \>30 * Metastasizing malignity * Patients after cardiopulmonary resuscitation (CPR) prior to admission * Cerebral edema * Cerebral trauma * Intracranial hypertension * Liver cirrhosis
Where this trial is running
Ostrava, Moravian-Silesian Region and 1 other locations
- University of Ostrava, Department of Physiology and Patophysiology — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
Study contacts
- Principal investigator: Marcela Káňová, MD, Ph.D. — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
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: Sepsis, Trauma, Respiratory Insufficiency, Surgery, polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction