Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition (MASS) (MASS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03825419|
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 4, 2019
|Condition or disease|
|Acute Ischemic Stroke|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- 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)
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
|Contact: Levent Gungor, MDemail@example.com|
|Contact: Ethem M Arsava, MDfirstname.lastname@example.org|
|Ankara University Faculty of Medicine||Active, not recruiting|
|Gazi University Faculty Of Medicine||Active, not recruiting|
|Hacettepe University Faculty of Medicine||Recruiting|
|Contact: Ethem M Arsava, MD 00905323355172 email@example.com|
|Contact: Mehmet A Topcuoglu, MD 005365753634 firstname.lastname@example.org|
|Principal Investigator: Ethem M Arsava, MD|
|Sub-Investigator: Mehmet A Topcuoglu, MD|
|Eskişehir Osmangazi Faculty of Medicine||Active, not recruiting|
|Gaziantep University Faculty of Medicine||Active, not recruiting|
|İstanbul Şişli Hamidiye Etfal Training and Research Hospital||Active, not recruiting|
|Dokuz Eylül University Faculty of Medicine||Active, not recruiting|
|Ege University Faculty of Medicine||Active, not recruiting|
|İzmir Katip Çelebi University Atatürk Training and Research Hospital||Active, not recruiting|
|Ondokuz Mayıs University Faculty of Medicine||Active, not recruiting|