Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Pilot Study and Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
II
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Research_Recruitment@jh.eduBrief Summary
This study proposes a novel early intervention combining Intravenous (IV) amino acids plus in-bed cycle ergometry exercise to improve physical outcomes in critically ill patients. The investigators hypothesize that this innovative approach will improve short-term physical functioning outcomes (primary outcome), as well as amino acid metabolism, body composition, and patient-reported outcomes at 6-month follow-up.
Eligibility
Inclusion Criteria:
- ≥18 years old.
- Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation ≥ 48 hours.
- Expected ICU stay ≥ 4 days after enrollment (to permit adequate exposure to the proposed intervention).
Exclusion Criteria:
- >96 continuous hours of mechanical ventilation before enrollment.
- Expected death or withdrawal of life-sustaining treatments within this hospitalization.
- No expectation for any nutritional intake within the subsequent 72 hours.
- Severe chronic liver disease (MELD score ≥20) or acute fulminant hepatitis.
- Documented allergy to the amino acid intervention.
- Metabolic disorders involving impaired nitrogen utilization
- Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted).
- Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre).
- Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met).
- Intracranial or spinal process affecting motor function
- Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment.
- Patients in hospital >5 days prior to ICU admission
- Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury).
- Remaining intubated for airway protection only
- Weight ≥150kg
- Physician declines patient enrollment
- Insufficient IV access
- Pregnant
- Incarcerated