Sarcopenia in Liver Cirrhosis Clinical Trial
Official title:
Assessment of Sarcopenia in Patients With Liver Cirrhosis and Its Prognostic Value in Liver Transplant Candidates
| Verified date | July 2018 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle
mass and strength, shown to be prevalent in adults with cancer and common chronic
comorbidities such as liver cirrhosis.
The EWGSOP identified a grading for Sarcopenia into pre-sarcopenia (decreased muscle mass
with normal strength and physical performance), sarcopenia (decreased muscle mass with
decreased strength or performance), severe Sarcopenia (decreased muscle mass, strength and
performance) .
Sarcopenia has emerged as an independent predictor of poor prognosis in a variety of clinical
conditions.Sarcopenia is clinically important because it can affectthe quality of life of
patients with cirrhosis .
Skeletal muscle mass is not only a good indicator of nutrition in patients with cirrhosis,
but also has recently been shown to be closely associated with survival prognosis and
postoperative complications inHCC.
Combination of sarcopenia and the Model for End-stage Liver Disease (MELD) has been shown to
be an excellent model for predicting prognosis in decompensated liver cirrhosis .
Most patients awaiting liver transplantation (LT) are more or less in a state of sarcopenia.
Several studies have reported that sarcopenia was associated with worse prognosis.In
addition, sarcopenia may be associated with a higher risk of post-transplant infection .
Assessment of sarcopenia in patients with liver cirrhosis:_ The European Working Group on
Sarcopenia in Older People recommended that the definition of sarcopenia include not only low
muscle mass but also low muscle function . They recommended cutoff values for muscle mass
measurements (7.26 kg/m2 for men and 5.5 kg/m2 for women using dual X-ray absorptiometry, and
8.87 kg/m2 for men and 6.42 kg/m2 for women using bioimpedance analysis, handgrip strength
(<30 kg for men and <20 kg for women), and usual gait speed (<0.8 m/s).
Aim of the study
- To evaluate sarcopenia in different stages of liver cirrhosis by different diagnostic
methods.
- To identify the prognostic value of CT in the diagnosis of sarcopenia .
- To identify effect of sarcopenia inliver transplant candidate.
Patients and methods:
Type of the study:the study is divided into two parts First part: observational descriptive
cross sectional study. Second part: follow up of liver transplant candidate group (pre and
post liver transplantation) Duration of study: expected duration of the study will be 1.5
years . The 1st part will include all patients admitted to the department for 1 year fulfill
inclusion criteria .
2nd part will be 6 ms follow up after liver transplantation. Study population
1. st part : Patients with liver cirrhosis will be evaluated for the presence of
sarcopenia.
2. nd part:
- 13 cases of liver cirrhosis already done liver transplantation in AL
Rajhiuneversitiy hospital(which data already recoreded) and any cirrhotic pts will
be prerared for liver transplantion within six months.
- Methods At the study entry, all candidates will be subjected to the following
parameters (and 3 month after LT for liver transplant candidates only)
- Clinical history
- Clinical examination
- Abdominal ultrasound
- Laboratory investigation:
- Liver function tests
- Complete blood picture,
- Kidney function tests,
- Serum glucose, serum Na+ and K+
- Hepatitis markers (HBsAg, HCV-Ab)
- Calculate:
= Child Pugh score (Pugh et al., 1973) and MELD (Wiesner et al., 2003) scores for
assessment ofliver cirrhosis.
- Anthropometric measurements:
- Triceps skin fold thickness (TSF) .
- Measure mid-arm circumference (MAC).
- Body mass index
- Hand grip to assess muscle strength
- Gait speed to assess physical performance
- Assessment of sarcopenia using CT scan:
- Assessment of sarcopenia using ultrasound:
- Assessment of sarcopenia using bioimpedance analysis
| Status | Not yet recruiting |
| Enrollment | 300 |
| Est. completion date | October 1, 2020 |
| Est. primary completion date | April 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients with liver cirrhosis. - Age: 18 - 65 years. Exclusion Criteria: Cirrhotic patients with: - Activecomorbid disease e.g. Diabetes mellitus, pulmonary, renal disease (especially .hepatorenal syndrome). - Malignancy - Receiving anabolic steroids |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| marwa abdElRazek Ahmed sala.a makhlof | Assiut University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | grading of sarcopenia in liver cirrhosis . | all patients will done CT abdomen with lower limit 38 in female and 53 in male which mean sarcopenia all patients wiill be measure height in cm by stadiometer . all pateints will measure weight in kilograms by weight measuring device. all pateints will be calculated BMI which mean weight\(height)2. with normal range 18.5 to 24.9 | about one and half year |