Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487728
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
The Validity of Urinary Titin and Skeletal Muscle Index as Predictor of Muscle Weakness in Critically Ill Patients A Prospective Cohort Study
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
The Validity of Urinary Titin and Skeletal Muscle Index as Predictor of Muscle Weakness in Critically Ill Patients A Prospective Cohort Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients height m2 on CT The possibility of using urinary titin and skeletal muscle index for early prediction of muscle weakness in critically ill patients
Detailed Description:
All patients will be subjected to the following
Informed consent will be obtained from patients History taking including age sex comorbidities current medications ethnicity reason for admission and body mass index BMI General clinical examination General laboratory investigations CBC Random blood sugar CRP ESR
Urinary Titin Measurement
The first urine sample will be collected using a urethral catheter within 12 h of ICU admission and 24-hour urine samples d 24-hour urine samples on days 2 3 5 and 7
Urinary titin will be measured using an ELISA kit Maruyama et al 2016
Skeletal Muscle Index calculation
This assessment calculates the skeletal muscle index SMI cm2m2 by dividing the cross-sectional area cm2 of the skeletal muscle at the level of the third lumbar vertebra L3 by the square of the patients height m2 on CT SMI measured using CT Mitobe et al 2019
Ultrasonographic Measurement
Rectus femoris muscle area and diaphragm thickness will be evaluated with serial ultrasound measurements on days 1 3 5 and 7 of ICU admission Recordings will be discontinued at death or ICU discharge Cross-sectional area of the rectus femoris muscle will be evaluated at the midway between the anterior superior iliac spine and the proximal 9 end of the patella A transducer will be placed perpendicularly to the long axis of the rectus femoris muscle with patients in the supine position under passive knee extension
The diaphragm will be evaluated at the zone of apposition on the right chest wall Its thickness will be measured during the end-expiration phase Beds will be adjusted at a 30 angle We will exclude patients whose diaphragm is unclear or difficult to measure
Patients will be divided into three groups according to the changes in diaphragm thickness atrophy unchanged and increased A 10 change in diaphragm thickness will be regarded as the cutoff value in the three groups Atrophy will be first classified with 10 decrease in diaphragm thickness from day 1 to the lowest value over the measurement period Thereafter increased thickness group will be classified when 10 increase is observed The rest of the patients were classified into the unchanged group as previously reported Nakanishi et al 2019 In the analysis the unchanged group will be compared with atrophy and increased groups and their combination because both increased and decreased diaphragm thickness significantly influence clinical outcomes Goligher et al 2018 Rectus femoris cross-sectional area and diaphragm thickness will be measured thrice and the median value was used for evaluation All measurements will be conducted by two examiners Intraclass and interclass correlation coefficients will be 099 and 099 for rectus femoris cross-sectional area and 095 and 095 for diaphragm thickness respectively
Physical Assessment and Mobilization
When patients are awake and attentive physical therapists will be evaluated the Medical Research Council MRC score and incidence of ICU-AW on days 1 and 7 of ICU admission Intact level of consciousness and awareness will be defined by patients response to at least three of five orders De Jonghe et al 2007
ICU-AW will be defined as an MRC score of 48 on two separate occasions Stevens et al 2009 We will use the incidence of ICU-AW following the last measurement for comparison 10 IMS is a measure of mobilization capabilities from 0 lying in bed to 10 walking independently Hodgson et al 2014 We will evaluate maximum IMS score during the study period because the maximum level of mobility is an important prognostic factor Kim et al 2019
Informed consent will be obtained from patients History taking including age sex comorbidities current medications ethnicity reason for admission and body mass index BMI General clinical examination General laboratory investigations CBC Random blood sugar CRP ESR
Urinary Titin Measurement
The first urine sample will be collected using a urethral catheter within 12 h of ICU admission and 24-hour urine samples d 24-hour urine samples on days 2 3 5 and 7
Urinary titin will be measured using an ELISA kit Maruyama et al 2016
Skeletal Muscle Index calculation
This assessment calculates the skeletal muscle index SMI cm2m2 by dividing the cross-sectional area cm2 of the skeletal muscle at the level of the third lumbar vertebra L3 by the square of the patients height m2 on CT SMI measured using CT Mitobe et al 2019
Ultrasonographic Measurement
Rectus femoris muscle area and diaphragm thickness will be evaluated with serial ultrasound measurements on days 1 3 5 and 7 of ICU admission Recordings will be discontinued at death or ICU discharge Cross-sectional area of the rectus femoris muscle will be evaluated at the midway between the anterior superior iliac spine and the proximal 9 end of the patella A transducer will be placed perpendicularly to the long axis of the rectus femoris muscle with patients in the supine position under passive knee extension
The diaphragm will be evaluated at the zone of apposition on the right chest wall Its thickness will be measured during the end-expiration phase Beds will be adjusted at a 30 angle We will exclude patients whose diaphragm is unclear or difficult to measure
Patients will be divided into three groups according to the changes in diaphragm thickness atrophy unchanged and increased A 10 change in diaphragm thickness will be regarded as the cutoff value in the three groups Atrophy will be first classified with 10 decrease in diaphragm thickness from day 1 to the lowest value over the measurement period Thereafter increased thickness group will be classified when 10 increase is observed The rest of the patients were classified into the unchanged group as previously reported Nakanishi et al 2019 In the analysis the unchanged group will be compared with atrophy and increased groups and their combination because both increased and decreased diaphragm thickness significantly influence clinical outcomes Goligher et al 2018 Rectus femoris cross-sectional area and diaphragm thickness will be measured thrice and the median value was used for evaluation All measurements will be conducted by two examiners Intraclass and interclass correlation coefficients will be 099 and 099 for rectus femoris cross-sectional area and 095 and 095 for diaphragm thickness respectively
Physical Assessment and Mobilization
When patients are awake and attentive physical therapists will be evaluated the Medical Research Council MRC score and incidence of ICU-AW on days 1 and 7 of ICU admission Intact level of consciousness and awareness will be defined by patients response to at least three of five orders De Jonghe et al 2007
ICU-AW will be defined as an MRC score of 48 on two separate occasions Stevens et al 2009 We will use the incidence of ICU-AW following the last measurement for comparison 10 IMS is a measure of mobilization capabilities from 0 lying in bed to 10 walking independently Hodgson et al 2014 We will evaluate maximum IMS score during the study period because the maximum level of mobility is an important prognostic factor Kim et al 2019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None