NCT06653998 Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients
| NCT ID | NCT06653998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Claudia Aristizábal |
| Condition | Intensive Care Unit Acquired Weakness |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2025-03 |
Trial Parameters
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Brief Summary
Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration. The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.
Eligibility Criteria
Inclusion Criteria: * Patients ≥ 18 years of age admitted to the intensive care units. Exclusion Criteria: * Patients requiring extracorporeal membrane oxygenation (ECMO). * Patients without indication for early mobilisation in the ICU (severe hemodynamic instability, acute brain or spinal injury with rest orders, anaemia (Hb \<8 mg/dl), thrombocytopenia (platelets \<50,000), active systemic inflammatory response according to institutional protocols). * Patients in the postoperative period of cardiac transplantation.