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Strength Testing After Nitrate Delivery (STAND) in ICU Patients

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ClinicalTrials.gov Identifier: NCT02293616
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
It is well documented that intensive care unit (ICU) patients have lower levels of skeletal muscle strength compared to non-ICU patients upon hospital discharge, and this weakness affects the patient's ability to perform basic activities of daily living upon hospital discharge and for extended periods thereafter. Recently, critically ill ICU patients have been shown to have lower nitric oxide levels. These patients often suffer from a disturbed homeostasis with circulatory and metabolic abnormalities that may potentially contribute to their ICU acquired weakness. Given the recent research showing dietary nitrate supplementation can increase nitric oxide levels and improve exercise tolerance in healthy and diseased older individuals, our aim is to investigate the importance of nitrate supplementation in ICU patients with focus on physical function and ICU acquired muscle weakness.

Condition or disease Intervention/treatment Phase
Respiratory Failure Dietary Supplement: Nitrate Rich Beetroot Juice Dietary Supplement: Placebo Not Applicable

Detailed Description:
The proposed study is an investigator initiated, double blind, placebo controlled experimental study designed to evaluate the effect of chronic NO3- supplementation via beetroot juice ingestion on the skeletal muscle strength and physical function in ICU patients. Patients will be randomized to receive either nitrate rich or nitrate depleted beetroot juice once daily during their ICU and hospital stay. Physical function and skeletal muscle strength will be measured at ICU (± 2 days) and hospital (± 2 days) discharge and 2 months (± 2 weeks) after enrollment. Plasma levels of nitrate and nitrite will be measured 1, 3 and 5 days after randomization into the trial and at ICU and hospital discharge. Skeletal muscle ultrasound will be performed to examine the size and echogenicity of patient muscles. Self-reported physical function will be measured using the Functional Performance Inventory Short Form (FPI-SF). The FPI-SF provides an overall score of patient self-reported functional performance in the areas of household maintenance, movement, family and social activities, work, avocation and recreation

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Strength Testing After Nitrate Delivery (STAND) in ICU Patients
Study Start Date : June 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Arm Intervention/treatment
Experimental: Nitrate Rich
A nitrate rich beetroot juice supplement (Beet It Shot®, James White Drinks, UK) high in nitrates will be provided to the subjects. Subject's diet will be supplemented once daily while hospitalized up to 14 days with one 70 ml bottle containing 300 mg of dietary nitrate.
Dietary Supplement: Nitrate Rich Beetroot Juice
Nitrate rich beetroot juice diet supplement will be consumed by subjects.
Other Name: Beet It Shot®

Placebo Comparator: Nitrate Depleted
This group will consume a beetroot juice supplement (Beet It Shot®, James White Drinks, UK) that has had the nitrate removed from the beverage by the manufacturer. Patient's diet will be supplemented once daily with one 70 ml bottle while hospitalized up to 14 days.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. physical function assessed using the Short Physical Performance Battery (SPPB) [ Time Frame: 2 months ]
    The SPPB is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each performance measure is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 inability to complete the test. A summary score (range 0-12) will be calculated by adding the three scores.


Secondary Outcome Measures :
  1. Plasma Nitrate and Nitrite Levels [ Time Frame: 5 days ]
    Blood samples will be collected in 4 mL lithium heparin vials. Nitrate and nitrite will be measured separately using the ENO-20 NOx analyzer.

  2. Skeletal muscle strength [ Time Frame: 2 months ]
    Skeletal muscle strength will be measured in both upper and lower extremities. Hand grip strength in both hands will be measured using a hand held grip strength dynamometer. Additionally, an electronic strength dynamometer will be used to collect strength measures of the elbow flexion, elbow extension, shoulder flexion in the scaption plane, ankle dorsiflexion, knee extension and hip extension, bilaterally. Skeletal muscle ultrasound will be performed on upper and lower extremities bilaterally.

  3. Hospital Length of Stay [ Time Frame: 2 weeks ]
    The hospital calendar days (or any portion of a calendar day) at the enrolling hospital and at any long term acute care facility to which the subject is directly transferred.



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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 55 years
  • Mechanically ventilated via an endotracheal tube or mask who have begun spontaneous breathing trials or extubated within the previous 24 hours
  • Lung Injury as defined by a PaO2 / FiO2 < 300

Exclusion Criteria:

  • Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
  • Cognitive impairment prior to acute ICU illness (non-verbal)
  • Acute stroke
  • Body mass index (BMI) >50
  • Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
  • Hip fracture, unstable cervical spine or pathological fracture
  • Mechanically Ventilated > 80 hours
  • Current hospitalization or transferring hospital stay > 7 days
  • DNR/DNI on admission
  • Cancer treatment within the last 6 months
  • Moribund
  • Participation in another research study
  • On nitroglycerine or nitrate preparations used with angina or phosphodiesterase type 5 inhibitors
  • Body mass less than 60 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293616


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: D. Clark Files, MD Wake Forest University Health Sciences

Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02293616     History of Changes
Other Study ID Numbers: IRB00030880
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
ICU
Respiratory Failure
Weakness
Nitrate supplementation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases