A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in Plasma Albumin Level from Baseline to Week 2
研究概览
简要总结
This study is a multicenter, randomized controlled trial aimed at evaluating the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients who have suffered moderate to severe acute brain injuries complicated by hypoproteinemia.
Eligible participants, aged 60 and older, with acute brain injuries and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.
Clinical data will be collected at baseline and weekly for four weeks. The primary outcome measure will be the change in plasma albumin levels from baseline to Week 2. Secondary outcome measures will include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rates, hemoglobin levels, length of hospital stays, length of intensive care unit stays, and functional outcomes.
Safety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence that can help optimize nutritional support and rehabilitation strategies for elderly patients with acute brain injuries.This study is a multicenter, randomized controlled clinical trial designed to evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.
Eligible participants aged 60 years and older with acute brain injury and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.
Clinical data will be collected at baseline and weekly for four weeks. The primary outcome is the change in plasma albumin level from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rate, hemoglobin level, length of hospital stay, intensive care unit stay, and functional outcomes.
Safety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence for optimizing nutritional support and rehabilitation strategies in elderly patients with acute brain injury.
详细描述
This study is a multicenter, prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.
Eligible patients aged 60 years and older who are diagnosed with moderate to severe acute brain injury and have serum albumin levels below 35 g/L will be enrolled. After obtaining informed consent, participants will be randomly assigned in a 1:1 ratio to either the rhGH treatment group or the control group using a centralized randomization system.
Patients in the treatment group will receive subcutaneous recombinant human growth hormone in addition to standard medical treatment and nutritional support. Patients in the control group will receive standard medical treatment and nutritional support alone. The dosage and duration of rhGH administration will follow the study protocol.
Baseline demographic data, medical history, and clinical characteristics will be collected at enrollment. Laboratory parameters including serum albumin, total protein, prealbumin, insulin-like growth factor-1, hemoglobin, and inflammatory markers will be measured at baseline and weekly for four weeks.
The primary outcome measure is the change in plasma albumin level from baseline to Week 2. Secondary outcome measures include changes in nutritional indicators, cumulative albumin infusion volume, incidence of infection, length of intensive care unit stay, total hospital stay, functional recovery, and mortality during hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years, male or female.
- •Hospitalized patients with acute brain injury (including traumatic brain injury, ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage) who had a Glasgow Coma Scale (GCS) score ≤ 12 at any time during hospitalization.
- •Presence of hypoalbuminemia, defined as serum albumin < 35 g/L and/or prealbumin < 200 mg/L after admission.
- •Willing and able to provide informed consent (by patient or legal representative).
排除标准
- •Unstable vital signs, defined as deviations in body temperature, respiration, pulse, blood pressure, or oxygen saturation from normal ranges that, in the clinical judgment of the investigator, may jeopardize vital organ perfusion or indicate disease progression.
- •Active malignancy or history of malignancy with a disease-free interval of less than 5 years.
- •Diabetes mellitus with retinopathy.
- •Any other condition deemed unsuitable for participation by the investigator (e.g., severe renal/hepatic dysfunction, active infection, known hypersensitivity to growth hormone, or participation in another interventional trial).
研究组 & 干预措施
rhGH Treatment Group
Participants receive recombinant human growth hormone according to the study protocol. The recommended dose is 2-4 IU per day. For participants with blood glucose ≥11.1 mmol/L or aged 80 years and older, the recommended dose is 2-3 IU per day.
干预措施: Recombinant Human Growth Hormone (rhGH) Injection (Drug)
rhGH Treatment Group
Participants receive recombinant human growth hormone according to the study protocol. The recommended dose is 2-4 IU per day. For participants with blood glucose ≥11.1 mmol/L or aged 80 years and older, the recommended dose is 2-3 IU per day.
干预措施: Standard Care (Treatment as Usual) (Other)
Standard Care Group
Participants receive standard clinical care or routine observation without recombinant human growth hormone, according to usual practice and individual clinical conditions.
干预措施: Standard Care (Treatment as Usual) (Other)
结局指标
主要结局
Change in Plasma Albumin Level from Baseline to Week 2
时间窗: Baseline (within 7 days before first treatment) and Week 2 (±2 days) after treatment initiation.
The difference in plasma albumin level (g/L) between baseline (before treatment) and at Week 2 (±2 days) after initiation of treatment. This outcome will be compared between the growth hormone treatment group and the blank control group to assess the short-term effect of recombinant human growth hormone (rhGH) on hypoalbuminemia in elderly patients with moderate to severe acute brain injury.
次要结局
- Change in Total Protein (TP) from Baseline to Weeks 1, 2, 3, and 4(Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- Change in Albumin (ALB) from Baseline to Weeks 1, 2, 3, and 4(Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- Change in Prealbumin (PA) from Baseline to Weeks 1, 2, 3, and 4(Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- Cumulative Amount of Albumin Infused(Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- 24-hour Urine Urea Nitrogen (24h UUN)(Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.)
- Change in Z-score of Plasma Insulin-like Growth Factor 1 (IGF-1) Level from Baseline(Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- Hemoglobin Level at Weeks 1, 2, 3, and 4(At weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- Cumulative Blood Transfusion(Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.)
- Cumulative Incidence and Infections(Up to Weeks 2 and 4 (±2 days) after treatment initiation)
- Time to First Infection(From treatment initiation to Week 4 (±2 days))
- C-reactive Protein (CRP) Level at Weeks 1, 2, 3, and 4(At weeks 1, 2, 3, 4 (±2 days) after treatment initiation)
- Total Lymphocyte Count at Weeks 1, 2, 3, and 4(At Weeks 1, 2, 3, and 4 (±2 days) after treatment initiation.)
- Length of Hospital Stay(From the date of hospital admission to the date of discharge for any reason, assessed up to 6 months.)
- Length of Intensive Care Unit (ICU) Stay(From the date of ICU admission to the date of ICU discharge, assessed up to 6 months)
- Glasgow Outcome Scale Extended (GOSE) Score at Week 4(At Week 4 (±2 days) after treatment initiation.)
- Duration of Mechanical Ventilation (Subgroup Analysis)(From the initiation of mechanical ventilation until the date of first successful extubation or death from any cause, whichever came first, assessed up to 6 months)
- Change in Hemoglobin in Anemic Subgroup (Hemoglobin < 95 g/L)(Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation)