NCT03825419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

January 30, 2019

Last Update Submit

April 26, 2022

Conditions

Acute Ischemic Stroke

Keywords

Stroke, Acute, Neurocritical Care, Nutrition, Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units for whom enteral nutrition is indicated

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Gazi University Faculty Of Medicine

Ankara, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Eskişehir Osmangazi Faculty of Medicine

Eskişehir, Turkey (Türkiye)

Location

Gaziantep University Faculty of Medicine

Gaziantep, Turkey (Türkiye)

Location

İstanbul Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylül University Faculty of Medicine

Izmir, Turkey (Türkiye)

Location

Ege University Faculty of Medicine

Izmir, Turkey (Türkiye)

Location

İzmir Katip Çelebi University Atatürk Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 28017450BACKGROUND

  • 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.

    PMID: 25676847BACKGROUND

  • 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. doi: 10.1001/jama.2013.278481.

    PMID: 24108501BACKGROUND

  • 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.

    PMID: 25726722BACKGROUND

  • Gungor 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.

    PMID: 36805095DERIVED

MeSH Terms

Conditions

Ischemic StrokeStrokeSarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

January 23, 2019

Primary Completion

June 30, 2020

Study Completion

November 30, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

TU(10)