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

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ClinicalTrials.gov Identifier: NCT03825419
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Abbott Nutrition
Klinar CRO
Turkish Neurological Society
Information provided by (Responsible Party):
Ethem Murat Arsava, Turkish Stroke Research and Clinical Trials Network

Brief Summary:
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.

Condition or disease
Acute Ischemic Stroke

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020



Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units for whom enteral nutrition is indicated
Criteria

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

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): NCT03825419


Contacts
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Contact: Levent Gungor, MD 00903623121919 ligungor@omu.edu.tr
Contact: Ethem M Arsava, MD 00905323355172 arsavaem@hotmail.com

Locations
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Turkey
Ankara University Faculty of Medicine Active, not recruiting
Ankara, Turkey
Gazi University Faculty Of Medicine Active, not recruiting
Ankara, Turkey
Hacettepe University Faculty of Medicine Recruiting
Ankara, Turkey
Contact: Ethem M Arsava, MD    00905323355172    arsavaem@hotmail.com   
Contact: Mehmet A Topcuoglu, MD    005365753634    matopcuoglu@yahoo.com   
Principal Investigator: Ethem M Arsava, MD         
Sub-Investigator: Mehmet A Topcuoglu, MD         
Eskişehir Osmangazi Faculty of Medicine Active, not recruiting
Eskişehir, Turkey
Gaziantep University Faculty of Medicine Active, not recruiting
Gaziantep, Turkey
İstanbul Şişli Hamidiye Etfal Training and Research Hospital Active, not recruiting
Istanbul, Turkey
Dokuz Eylül University Faculty of Medicine Active, not recruiting
İzmir, Turkey
Ege University Faculty of Medicine Active, not recruiting
İzmir, Turkey
İzmir Katip Çelebi University Atatürk Training and Research Hospital Active, not recruiting
İzmir, Turkey
Ondokuz Mayıs University Faculty of Medicine Active, not recruiting
Samsun, Turkey
Sponsors and Collaborators
Turkish Stroke Research and Clinical Trials Network
Abbott Nutrition
Klinar CRO
Turkish Neurological Society

Publications:
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Responsible Party: Ethem Murat Arsava, Prof.Dr., Turkish Stroke Research and Clinical Trials Network
ClinicalTrials.gov Identifier: NCT03825419     History of Changes
Other Study ID Numbers: MASS
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Ethem Murat Arsava, Turkish Stroke Research and Clinical Trials Network:
Stroke, Acute, Neurocritical Care, Nutrition, Sarcopenia

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases