Acute Ischemic StrokeMASSNCT03825419
Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition (MASS)
An observational study of Acute Ischemic Stroke, run by Turkish Stroke Research and Clinical Trials Network at 10 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 125 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 23 Jan 2019to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units for whom enteral nutrition is indicated
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Turkey (Türkiye)10 sites
Ankara University Faculty of Medicine
Ankara
Gazi University Faculty Of Medicine
Ankara
Hacettepe University Faculty of Medicine
Ankara
Eskişehir Osmangazi Faculty of Medicine
Eskişehir
Gaziantep University Faculty of Medicine
Gaziantep
İstanbul Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
Dokuz Eylül University Faculty of Medicine
Izmir
Ege University Faculty of Medicine
Izmir
İzmir Katip Çelebi University Atatürk Training and Research Hospital
Izmir
Ondokuz Mayıs University Faculty of Medicine
Samsun
About this study
Official title: Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Acute, Neurocritical Care, Nutrition, Sarcopenia
- Medical subject headings
- Ischemic Stroke, Stroke, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass
Comparison of anthropometric measurements and CT based muscle mass measurements obtained at admission and at day 14 (± 3 days)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Jan 2019
- Primary completion30 Jun 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Stroke Research and Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- Abbott Nutrition, Klinar CRO, Turkish Neurological Society
- Responsible party
- Principal investigator, Ethem Murat Arsava, Turkish Stroke Research and Clinical Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825419
- Sponsor's protocol ID
- MASS
- Acronym
- MASS
- Status last verified
- Apr 2022
- First submitted
- 30 Jan 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28017450Scherbakov 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.
PubMed 25676847Puthucheary 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. doi: 10.1001/jama.2013.278481.
PubMed 24108501Coelen 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.
PubMed 25726722Gungor L, Arsava EM, Guler A, Togay Isikay C, Aykac O, Batur Caglayan HZ, Kozak HH, Aydingoz U, Topcuoglu MA; MASS investigators. Determinants of in-hospital muscle loss in acute ischemic stroke - Results of the Muscle Assessment in Stroke Study (MASS). Clin Nutr. 2023 Mar;42(3):431-439. doi: 10.1016/j.clnu.2023.01.017. Epub 2023 Feb 3.
PubMed 36805095
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition
- ClinicalTrials.gov ID
- NCT03825419
- Acronym / sponsor ID
- MASS / MASS
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Acute, Neurocritical Care, Nutrition, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Turkish Stroke Research and Clinical Trials NetworkResearch network
- Collaborators
- Abbott Nutrition, Klinar CRO, Turkish Neurological Society
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units for whom enteral nutrition is indicated
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Retained ability for oral feeding
- Known muscle disease, neuropathy, neuromuscular junction disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 28017450Shiraishi 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.
- Background: PubMed 25676847Scherbakov 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.
- Background: PubMed 24108501Puthucheary 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. doi: 10.1001/jama.2013.278481.
- Background: PubMed 25726722Coelen 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.
- Derived from this study: PubMed 36805095Gungor L, Arsava EM, Guler A, Togay Isikay C, Aykac O, Batur Caglayan HZ, Kozak HH, Aydingoz U, Topcuoglu MA; MASS investigators. Determinants of in-hospital muscle loss in acute ischemic stroke - Results of the Muscle Assessment in Stroke Study (MASS). Clin Nutr. 2023 Mar;42(3):431-439. doi: 10.1016/j.clnu.2023.01.017. Epub 2023 Feb 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Turkish Stroke Research and Clinical Trials Network at 10 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03825419, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.