Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05157308 |
| Other study ID # |
CIRR |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2020 |
| Est. completion date |
December 25, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Asian Institute of Gastroenterology, India |
| Contact |
Subhankar Dr Godbole, MBBS MD |
| Phone |
9420562114 |
| Email |
shubhu1308[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Cirrhosis is associated with a wide variety of metabolic changes in the body. Ascites,
hepatic encephalopathy, variceal bleeding, renal dysfunction, and hepatocellular carcinoma
are the most widely recognised complications in cirrhosis. Malnutrition and muscle wasting
(sarcopenia) constitute common complications, which are generally overlooked, but which
negatively impact the survival, quality of life, and response to stressors like infections,
sepsis and surgery in cirrhotic patients.
Cirrhotic patients with sarcopenia and myosteatosis have a higher risk of overt hepatic
encephalopathy and hyperammonemia.1 It has also been shown that the patients with sarcopenia
have a lower overall survival than those without sarcopenia.
The aim of the current study is to study the prevalence of myosteatosis and sarcopenia in
cirrhotic patients, and to compare the clinical and anthropometric parameters for sarcopenia
and myosteatosis to that of imaging parameters (CT based diagnosis).
We hypothesize that myosteatosis and sarcopenia can be estimated better with the use of CT
scan as compared with clinical assessment and hence, may help in early diagnosis of these
conditions.
Description:
All the patients of liver cirrhosis who attend the Liver clinic of the hospital will undergo
a thorough history and examination. After strict inclusion-exclusion criteria patients will
be included in the study. All routine investigations required to establish the etiology of
cirrhosis and to evaluate the stage of cirrhosis (Child-Turcotte-Pugh status and MELD score)
would be done.
The patient will be assessed for the following anthropometric measurements -
1. Body mass index (BMI) will be calculated. In patients with Ascites- Dry body weight (kg)
will be taken by- Post-paracentesis weight (kg) recorded before fluid retention (if
available). OR Subtracting a percentage of weight based upon the severity of ascites
(Mild Ascites- 5%, Moderate- 10%, Severe- 15%) with an additional 5% subtracted if
bilateral pedal oedema is present.
2. Mid- arm circumference (MUAC) - is the circumference of the left upper arm, measured at
the mid-point between the tip of the shoulder and the tip of the elbow (olecranon
process and the acromium). Normal value is 29.3 in males and 28.5 mm in females.
3. Triceps Skin fold thickness - assessed in the mid arm using skin fold callipers. Normal
values in adults are usually 12.5 mm in males and 16.5 mm in female.
4. Mid-arm Muscle circumference (MAMC) - defined as (mid arm circumference - triceps skin
fold) x 0.314. Normal values in are 25.3 mm and 23.2 mm in adult males and females
respectively.
The patients will be assessed for the indicators of muscle strength by-
1. 6 min walk Test - It measures the distance that patients can quickly walk in a flat,
hard surface within 6 minute. Values > 300 m in 6 min is considered normal, while < or
equal to 300 is considered low endurance while < 250m indicates frailty.
2. Balancing test - It is measured as the number of seconds that the subject can balance in
three positions (feet placed side-to-side, semi-tandem, and tandem) for a maximum of 10
seconds each. The duration is recorded for each.
3. Five times sit to stand test - The subject is to sit in the chair with arms crossed over
his/her chest and then to stand up as quickly as possible safely, five times without
using his/her arms. Normal person should be able to do it within 12 seconds.
4. Hand Grip test - It is a function of skeletal muscle contractile strength. It would be
tested using a hand held dynamometer and the average of three readings the subject's
dominant hand would be taken. The same would be compared with the normative data for the
age and sex of the patient.
5. Short physical performance battery - which consists of timed repeated chair stands,
balance testing, and a timed 13-ft walk
6. Liver frailty index - calculated based upon HG, and balancing test.
After the anthropometric and bedside maneuvers, patient will be subjected to plain Computed
tomographic (CT) scan of abdomen. CT image analysis at the L3 vertebra is almost universally
recognised as a specific method to quantify muscle loss. It will be done to assess the degree
of sarcopenia and myosteatosis as per the criteria.
- Total cross sectional area cm2 of abdominal skeletal muscle normalized to height =
skeletal muscle index ( cm2/m2)
- Cut off for sarcopenia: 50 cm2/m2 (male) and 39 cm2/m2 (Female) It has been established
to have an independent association with pooled transplantation mortality - HR : 1.84
independent of MELD.
- Cut-off for myosteatosis will be taken as Skeletal muscle radiation attenuation (SM-RA)
<41 HU for patients with a body mass index [BMI] up to 24.9 kg/m2 and <33 HU for
patients with a BMI ≥25 kg/m2.
