Recombinant Human Growth Hormone Trial to Assess Albumin Levels in Elderly Acute Brain Injury Patients

Elderly patients suffering from moderate to severe acute brain injury often face complications like hypoproteinemia, a condition characterized by low serum protein levels, particularly albumin. This can significantly worsen patient outcomes, increasing infection rates, prolonging hospital stays, and hindering recovery. Current standard medical care often struggles to adequately address this nutritional deficit, highlighting a critical need for interventions that can improve protein synthesis and overall nutritional status. Recombinant human growth hormone (rhGH) is being investigated due to its known anabolic effects, including stimulating protein synthesis and promoting tissue repair, which could potentially counteract the catabolic state induced by severe injury.

This multicenter, randomized controlled trial (RCT) is designed to assess the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients (aged 60 years and older) with acute brain injuries complicated by low serum albumin levels. Participants will be randomly assigned to either a treatment group, receiving rhGH in addition to standard medical care, or a control group, receiving standard care alone. Clinical data, including various protein markers, will be collected at baseline and weekly for four weeks. The primary outcome measure is the change in plasma albumin levels from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 (IGF-1) levels, cumulative albumin infusion, infection rates, hemoglobin levels, and lengths of hospital and ICU stays, alongside functional outcomes. Safety outcomes and adverse events will be continuously monitored.

This study describes a planned randomized controlled trial (GH-ABI-RCT), and as such, specific efficacy or safety results are not yet available. The trial aims to provide evidence on whether rhGH can significantly improve nutritional support and rehabilitation strategies in this vulnerable patient population. The primary endpoint is the change in plasma albumin levels from baseline to Week 2, with secondary endpoints including total protein, prealbumin, and IGF-1 levels, as well as clinical outcomes like infection rates and length of hospital stay. The study is designed to rigorously monitor adverse events and safety throughout the treatment period. The investigators anticipate that the findings will help optimize care for elderly patients with acute brain injury and hypoproteinemia.