Efficacy and safety of individual nutrition support in patients with hepatitis B virus-related acute-on-chronic liver failure at nutrition risk: a study protocol for a randomised controlled clinical trial

Introduction
Malnutrition is a common complication of hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) typically associated with poor prognosis. Despite nutritional treatment, the outcomes for these patients are limited by the symptoms and complications associated with ACLF. So far, the benefits of nutritional interventions in these populations have not been proven. This study aims to explore a new nutritional intervention method for patients with HBV-ACLF and evaluate its safety and efficacy.

Methods and analysis
This study is an investigator-initiated, nonblind, randomised controlled clinical trial. We will recruit 60 patients with HBV-ACLF according to the Chinese Group on the Study of Severe Hepatitis B criteria hospitalised in the Infectious Diseases Department of the Third Affiliated Hospital of Sun Yat-Sen University. Eligible patients will be randomly allocated to the nutrition support group (intervention group) and the control group in a 1:1 ratio. Patients in the nutrition support group will receive 10 days of tailor-made nutrition therapy consisting of oral nutritional supplements and supplementary parenteral nutrition. Patients in the control group will receive standard nutrition with dietary advice. All assessments will be conducted at baseline, 30 days and 90 days. The primary outcome measure is the liver transplant-free mortality rate. The secondary indicators include the incidence of clinical adverse outcomes and changes in indicators such as muscle mass, muscle strength, physical function and quality of life (EQ-5D scale).

Ethics and dissemination
This study has been approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University (approval number: II2023-242-03). The results and conclusions of the clinical trial will be published in academic conferences or journals.

Trial registration number
NCT06128421.

Leggi
Dicembre 2024

Defining within-host SARS-CoV-2 RNA viral load kinetics during acute COVID-19 infection within different respiratory compartments and their respective associations with host infectiousness: a protocol for a systematic review and meta-analysis

Introduction
Understanding how RNA viral load changes (viral load kinetics) during acute infection in SARS-CoV-2 can help to identify when and which patients are most infectious. We seek to summarise existing data on the longitudinal RNA viral load kinetics of SARS-CoV-2 sampled from different parts of the respiratory tract (nose, nasopharynx, oropharynx, saliva and exhaled breath) and how this may vary with age, sex, ethnicity, immune status, disease severity, vaccination, treatment and virus variant.

Methods and analysis
We will conduct a systematic review and meta-analysis, using studies identified through MEDLINE and EMBASE (via Ovid). All research studies reporting primary data on longitudinal RNA viral load kinetics of infected patients with SARS-CoV-2 will be included. Methodological quality will be assessed using a validated checklist for longitudinal studies as well as predefined quality criteria for assessment of individual-level RNA viral load. Should the data allow, we will aim to perform individual patient-level meta-analysis. Our primary outcomes are duration to, and quantity of peak RNA viral load, and total duration of viral load shedding within different respiratory compartments. Secondary outcomes include duration of lateral flow antigen and virus culture positivity and variation of RNA viral load by age, immune status, disease severity, vaccination, treatment, lateral flow tests, viral culture positivity and SARS-CoV-2 variant. Study-level effects affecting observations, but not related to properties of the patient, such as the PCR platform and gene target will also be recorded. Random-effects models will estimate the population mean and individual-level variation in viral shedding conditional on the aforementioned variables. Finally, we will summarise the key mechanistic models used in the literature to reconstruct individual-level viral kinetics and estimate how different factors shape viral dynamics over time.

Ethics and dissemination
Ethical approval is not needed as data will be obtained from published articles or studies with data that have already received and ethical review for analysis. Manuscript(s) will be prepared for publication.

Systematic review protocol registration
PROSPERO ID: CRD42023385315

Leggi
Dicembre 2024