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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03021902
Other study ID # The NEXIS Trial
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2017
Est. completion date March 2022

Study information

Verified date August 2021
Source Clinical Evaluation Research Unit at Kingston General Hospital
Contact Daren K Heyland, MD, MSc
Phone 403-915-5573
Email dkh2@queensu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
IV amino acids
IV amino acids delivered by continuous infusion, such that the total enteral and IV protein will be between 2.0-2.5 g/kg/day as a combination of amino acid infusion plus standard feeding.
Device:
In-bed cycle ergometry exercise
In-bed cycle ergometry exercise delivered in 45-minute sessions once-daily 5 days per week according to a detailed specific protocol that includes a safety check in combination with vigorous verbal encouragement from trained research staff delivering the intervention to promote active cycling. Cycling is protocolized to provide graduated increases in resistance during each session and between daily sessions. Cycling will continue through ICU discharge or 21 calendar days after randomization. The intervention will specifically occur during ICU stay.

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland
United States University of Vermont College of Medicine Burlington Vermont
United States University of Kentucky Lexington Kentucky
United States Oregon Health & Science University Portland Oregon
United States Harborview Medical Center Seattle Washington
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Clinical Evaluation Research Unit at Kingston General Hospital Johns Hopkins University, University of Vermont

Country where clinical trial is conducted

United States, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary Physical functioning 6-minute walk distance Hospital discharge (up to 26 weeks after randomization)
Secondary Overall strength-upper extremity MRC Sum-score (Medical Research Council (MRC) Scale for Muscle Strength). Subscales scored 0-5, where 5 is normal. Total score is the sum of the 6 upper extremity subscales. Hospital discharge (up to 26 weeks after randomization)
Secondary Overall strength-lower extremity MRC Sum-score (Medical Research Council (MRC) Scale for Muscle Strength). Subscales scored 0-5, where 5 is normal. Total score is the sum of the 6 lower extremity subscales. Hospital discharge (up to 26 weeks after randomization)
Secondary Quadriceps force-lower extremity strength Hand held dynamometry Hospital discharge (up to 26 weeks after randomization)
Secondary Distal strength-hand grip strength Hand held dynamometry ICU and hospital discharge (up to 26 weeks after randomization)
Secondary Overall Physical Functional status - Short Physical Performance Battery Short Physical Performance Battery ICU and hospital discharge (up to 26 weeks after randomization)
Secondary Overall Physical Functional status - Functional Status Score - ICU Functional Status Score - ICU 5 items are performed: rolling, transfer from supine to sit, sitting at the edge of bed, transfer from sit to stand, and walking Each task is evaluated using an eight-point ordinal scale ranging from 0 (unable to perform) to 7 (complete independence) Item scores are summed The total score ranges from 0-35, with higher scores indicating better physical functioning. ICU and hospital discharge (up to 26 weeks after randomization)
Secondary Mortality Chart review ICU and hospital discharge (up to 26 weeks after randomization)
Secondary Length of ventilation Chart review ICU and hospital discharge (up to 26 weeks after randomization)
Secondary ICU stay Chart review ICU and hospital discharge (up to 26 weeks after randomization)
Secondary Hospital stay Chart review ICU and hospital discharge (up to 26 weeks after randomization)
Secondary ICU readmission Chart review Hospital discharge (up to 26 weeks after randomization)
Secondary Re-intubation Chart review Hospital discharge (up to 26 weeks after randomization)
Secondary Hospital-acquired infections Chart review Hospital discharge (up to 26 weeks after randomization)
Secondary Discharge location (e.g. home vs. rehab) Chart review Hospital discharge (up to 26 weeks after randomization)
Secondary Body composition - Ultrasound Ultrasound of quadriceps Enrollment, hospital discharge, & ICU discharge (up to 26 weeks after randomization)
Secondary Body composition - CT - Chest when clinically available Chest CT Enrollment, hospital discharge, & ICU discharge (up to 26 weeks after randomization)
Secondary Body composition - CT - Abdominal Scan when clinically available Abdominal CT scan at 3rd lumbar vertebra Enrollment, hospital discharge, & ICU discharge (up to 26 weeks after randomization)
Secondary Health-related quality of life - SF-36 36-Item Short Form Health Survey (SF-36) All items are scored so that a high score defines a more favorable health state.
Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100 Items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores.
Scale scores represent the average for all items in the scale that the respondent answered.
Telephone survey at 6 months
Secondary Health-related quality of life - EQ-5D-5L EuroQol Group standardized measure of health status (EQ-5D-5L) Telephone survey at 6 months
Secondary Physical functioning - Katz ADL Katz Index of Independence in Activities of Daily Living (Katz ADL) Total score where 6 = High (patient independent) 0 = Low (patient very dependent) Hospital discharge (proxy) and telephone survey at 6 months
Secondary Physical functioning - Lawton IADL Lawton Instrument Activities of Daily Living Scale (Lawton IADL) A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias. Telephone survey at 6 months
Secondary Physical functioning/participation - return to work Return to baseline work/activity Telephone survey at 6 months
Secondary Physical functioning/participation - living location Living location Telephone survey at 6 months
Secondary Mental and Cognitive Functioning - MoCA-BLIND MoCA-BLIND The total possible score is 22 points; a score of 18 or above is considered normal Telephone survey at 6 months
Secondary Mental and Cognitive Functioning - HADS Hospital Anxiety and Depression Scale The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. Telephone survey at 6 months
Secondary Mental and Cognitive Functioning - IES-R Impact of Events Scale Scoring for each item ranges from 0-4 Total score ranges from 0-88, where a total score of 33 or over signifies the likely presence of PTSD Telephone survey at 6 months
Secondary Health Care Resource Utilization Admission to ICU, hospital, rehabilitation & nursing facility Telephone survey at 6 months
Secondary Body composition - DEXA Scan Whole Body DEXA Scan At Hospital Discharge
Secondary Body Composition - Heavy water Fat-free and fat mass can be measured with D2O in body fluids using gas chromatography-tandem mass spectrometry. Enrollment, Days 1-7
Secondary Plasma and muscle protein synthesis - Heavy water Muscle protein synthesis will be analyzed with chromatography and mass spectrometry techniques. Enrollment, Days 1-7
Secondary NEXIS FLAME - Circulating inflammatory mediators Blood IL-17, IL-23, IL-6, TNFa, CXCK1, CXCL5, CXCL8, CCL2, SP-D, KL-6, vWF, and leukocyte counts with differential Enrollment, Days 3, 5, and 8
Secondary NEXIS FLAME - Lung Inflammation Bronchoalveolar lavage neutrophil counts, IL-17A, CXCL5, and protein Enrollment, Day 5
Secondary NEXIS FLAME - Muscle area Single muscle fiber cross-sectional area (CSA), UPS expression, MuRF1 expression, myosin protein content (all from vastus lateralis sampling) Enrollment, Day 5
Secondary NEXIS FLAME - Muscle inflammation Muscle macrophages (CD45+, CD206+) Enrollment, Day 5
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