Trial intelligence / Profile preview

NEXIS: Nutrition and Exercise in Critical Illness

NCT03021902Phase 2

Key facts

Status: Completed
Start: Sep 2017
Primary completion: Jan 2025
Countries: 1
Sponsor: Kingston General Hospital
Modality: Recombinant Proteins and Enzymes

Drugs: clinisol
Conditions: acute respiratory failure (ARF)

Overview

Phase 2, randomised, single-blind trial of clinisol in acute respiratory failure (ARF) (2 arms), sponsored by Kingston General Hospital. Primary endpoint: Six-Minute Walk Distance. Started Sep 2017; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

IV amino acid + in-bed cycle ergometry
IV amino acids (Clinisol) + In-bed cycle ergometry exercise
Usual care
Standard of care nutrition and exercise

Who it enrols

Adult patients with acute respiratory failure requiring mechanical ventilation for >= 48 hours and expected ICU stay >= 4 days. Excludes patients with severe liver disease, AKI, weight >= 150kg, or inability to ambulate prior to illness.

Endpoints

Primary

Six-Minute Walk DistanceHospital discharge

Secondary

Overall strength-upper and lower extremityHospital discharge
Distal strength-hand grip strengthHospital discharge
Short Physical Performance BatteryHospital discharge
Functional Status Score - ICUHospital discharge
MortalityHospital discharge
Length of ventilationHospital discharge
ICU stayICU discharge
Hospital stayHospital discharge

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