The Validity of Urinary Titin and Skeletal Muscle Index as Predictor of Muscle Weakness in Critically Ill Patients. A Prospective Cohort Study

NCT06487728 | Enrolling By Invitation DMC

• 1 other identifier: 386/10-June 2024
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

Although skeletal muscle atrophy is common in critically ill patients, biomarkers associated with muscle atrophy have not been identified reliably. Titin is a spring-like protein found in muscles and has become a measurable biomarker for muscle breakdown and intensive care unit-acquired weakness in critically ill patients, in whom titin loss is a possible pathophysiology. The skeletal muscle index (SMI) is an alternative biomarker for muscle weakness, which is calculated by dividing the cross-sectional area (cm2) of the skeletal muscle at the level of the third lumbar vertebra by the square of the patient's height (m2) on CT The possibility of using urinary titin and skeletal muscle index for early prediction of muscle weakness in critically ill patients.

Conditions

Urinary Titin

Outcome Measures

Primary Outcomes (1)

• The relationship between cumulative urinary titin level and rate of rectus femoris muscle atrophy on days 1 and 7 of ICU admission

  Measurement of urinary titin level and its correlation to muscle index

  At day 1 and 7 day of icu admission

Interventions

Urinary titin DIAGNOSTIC_TEST

Urinary titin and skeletal muscle index as predictor of muscle wasting in critically ill patient

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Both sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients

You may qualify if:

• Consent from relatives of first degree. Consecutive adult patients who will be expected to remain in ICU for \>5 days will be enrolled. Nonsurgical critically ill patients will be included because surgical insult reportedly increased urinary titin level (Tanihata et al., 2019). Age more than 18 years. Both male and female.

You may not qualify if:

• Surgery not including percutaneous abscess drainage. Patients with expected prehospital functional status of \<48 hours. Chest tube insertion, and tracheostomy in ICU. 8 Current pregnancy. Diagnosis of primary neuromuscular disease. Trauma at the measurement point.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, Zagazig university

Zagazig, Sharqia Province, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)