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Completed

NCT Number: NCT03825419

Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition (MASS)

The degree of muscle loss over the course of inpatient stay will be evaluated in patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units and necessitating enteral nutrition.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Medicine, Ankara, Turkey (Türkiye)

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About this study

This study is a multicenter, prospective observational study. The study period is 12 months. There are no investigational products to be followed or used in the study.

Demographic data, stroke subtype, lesion localization, anthropometric measures will be recorded. Muscle in three different anatomical sites will be measured by CT following admission in patients included in the study.

For anthropometric measurements, height, body weight, body mass index, waist circumference, triceps skin thickness and calf circumference values will be used.

The muscle mass will be measured from the paraspinal muscles at the L3 vertebra level and from the muscles around the humerus and femur on the non-paralytic side of the extremities by CT.

All patients will receive standard enteral nutritional support with a standardized calorie and protein-based protocol recommended by international guidelines. The choice of the commercial enteral product will be left to the investigator, without any encouragement or restriction for use of any commercial product.

The enteral nutrition protocol will be implemented as follows;

  • Nasogastric or nasojejunal access
  • Continuous infusion
  • Targeted daily calories - 25-30 kcal / kg
  • Targeted daily protein - 1.2-1.5 gr / kg
  • 20 ml / h initial infusion rate
  • Increase infusion rate by 10-20 ml / h in 8-12 hours
  • Targeted calorie-protein requirement will be reached at the end of 72 hours.

Patients will continue their routine follow-up in the neurology intensive care unit / stroke unit / neurology department. Daily enteral nutrition dose, complications attributed to enteral nutrition and systemic comorbidities will be recorded. Anthropometric measurements and muscle mass measurements with CT at three different locations will be repeated at the end of the second week (14 days ± 3 days) .

The study will evaluate whether or not muscle mass develops 14 days after acute ischemic stroke. The end points of the study is deterioration of anthropometric measurements and loss of muscle mass demonstrated by CT at follow up. The differences between patients with and without muscle loss will be assessed from the the aspects of demographic characteristics, ischemic stroke subtype, comorbidities and the success attained in reaching enteral nutritional goals.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients to be included in this study are required to meet all of the following inclusion criteria:

  • Acute ischemic stroke
  • Admission within first 24 hours after symptom onset
  • Admission NIHSS score > 8
  • Being unable to walk
  • Need for enteral tube feeding due to problems with consciousness or dysphagia

Exclusion criteria

Patients with any of the following exclusion criteria can not be included in the study:

  • Retained ability for oral feeding
  • Known muscle disease, neuropathy, neuromuscular junction disease

Treatment and study plan

Primary outcomes

  1. Change in muscle mass

    Time frame: 14 days

    Comparison of anthropometric measurements and CT based muscle mass measurements obtained at admission and at day 14 (± 3 days)

Sponsors and collaborators

Lead sponsor

Turkish Stroke Research and Clinical Trials Network

Network

Collaborators

  • Abbott Nutrition
  • Klinar CRO
  • Turkish Neurological Society

Registry information

Official study title

Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition

Acronym: MASS

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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