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

Acute Ischemic Stroke Clinical Trial

— MASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825419
• Other study ID #: MASS
• Status: Completed
• Start date: January 23, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2022
• Source: Turkish Stroke Research and Clinical Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 30, 2021
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine	Ankara
Turkey	Gazi University Faculty Of Medicine	Ankara
Turkey	Hacettepe University Faculty of Medicine	Ankara
Turkey	Eskisehir Osmangazi Faculty of Medicine	Eskisehir
Turkey	Gaziantep University Faculty of Medicine	Gaziantep
Turkey	Istanbul Sisli Hamidiye Etfal Training and Research Hospital	Istanbul
Turkey	Dokuz Eylül University Faculty of Medicine	Izmir
Turkey	Ege University Faculty of Medicine	Izmir
Turkey	Izmir Katip Çelebi University Atatürk Training and Research Hospital	Izmir
Turkey	Ondokuz Mayis University Faculty of Medicine	Samsun

Sponsors (4)

Lead Sponsor	Collaborator
Turkish Stroke Research and Clinical Trials Network	Abbott Nutrition, Klinar CRO, Turkish Neurological Society

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Coelen RJ, Wiggers JK, Nio CY, Besselink MG, Busch OR, Gouma DJ, van Gulik TM. Preoperative computed tomography assessment of skeletal muscle mass is valuable in predicting outcomes following hepatectomy for perihilar cholangiocarcinoma. HPB (Oxford). 2015 Jun;17(6):520-8. doi: 10.1111/hpb.12394. Epub 2015 Feb 28. — View Citation

Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. Erratum in: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation

Scherbakov N, Sandek A, Doehner W. Stroke-related sarcopenia: specific characteristics. J Am Med Dir Assoc. 2015 Apr;16(4):272-6. doi: 10.1016/j.jamda.2014.12.007. Epub 2015 Feb 10. Review. — View Citation

Shiraishi A, Yoshimura Y, Wakabayashi H, Tsuji Y. Prevalence of stroke-related sarcopenia and its association with poor oral status in post-acute stroke patients: Implications for oral sarcopenia. Clin Nutr. 2018 Feb;37(1):204-207. doi: 10.1016/j.clnu.2016.12.002. Epub 2016 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle mass	Comparison of anthropometric measurements and CT based muscle mass measurements obtained at admission and at day 14 (± 3 days)	14 days