A Prospective Clinical Study Evaluating the Effectiveness and Safety of Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for Varying Degrees of Hypophosphatemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period.
研究概览
简要总结
The purpose of this clinical trial is to evaluate the efficacy and safety of Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the treatment of participants with mild, moderate, and severe hypophosphatemia. The main questions it aims to answer are:
Does enteral supplementation of Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules elevate participants' serum phosphorus? Does enteral supplementation of Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules cause gastrointestinal complications? Participants with hypophosphatemia will receive Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules orally or via nasogastric tube to observe the efficacy and safety of enteral phosphate supplementation.
Participants will take Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules daily, with varying doses based on the severity of hypophosphatemia, for a maximum of 14 days. The effect of phosphate supplementation will be assessed daily through blood draws, and their gastrointestinal symptoms will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years (inclusive), regardless of gender;
- •ICU inpatients with a serum phosphate concentration <0.80 mmol/L, and for whom the clinician determines phosphate supplementation is required;
- •Ability to receive enteral nutrition, with a daily enteral caloric intake ≥10 kcal/kg/day;
- •The subject or their legal guardian fully understands the purpose and significance of this trial, voluntarily agrees to participate, provides written informed consent, and is willing to strictly adhere to the clinical study protocol and complete the study.
排除标准
- •Pregnant and lactating women;
- •Patients with contraindications for enteral administration, such as acute upper gastrointestinal bleeding, mechanical intestinal obstruction, severe acute pancreatitis, digestive tract fistula, gastrointestinal dysfunction, intra-abdominal hypertension, enteral feeding intolerance, or continuous gastrointestinal decompression;
- •Expected ICU stay ≤96 hours;
- •Known allergy to any component of the investigational drug or drugs with a similar chemical structure;
- •Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²;
- •Subjects with hyperthyroidism requiring clinical intervention;
- •Subjects requiring sodium restriction;
- •Other conditions deemed by the investigator as unsuitable for inclusion.
研究组 & 干预措施
Mild Hypophosphatemia Group
Mild hypophosphatemia is defined as a serum phosphorus level of 0.65-0.80 mmol/L. For subjects with mild hypophosphatemia, the phosphorus supplementation dose is 0.306 mmol/(kg·d) based on the subject's actual body weight. During treatment, venous blood is drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the effectiveness of supplementation. The investigator determines the severity of hypophosphatemia based on the day's serum phosphorus level and administers the corresponding phosphorus supplementation dose for mild, moderate, or severe cases.
干预措施: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules (Drug)
Moderate Hypophosphatemia Group
Moderate hypophosphatemia is defined as a serum phosphorus level of 0.32-0.64 mmol/L. For subjects with moderate hypophosphatemia, the phosphorus supplementation dose is 0.612 mmol/(kg·d) based on the subject's actual body weight. During treatment, venous blood is drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the effectiveness of supplementation. The investigator determines the severity of hypophosphatemia based on the day's serum phosphorus level and administers the corresponding phosphorus supplementation dose for mild, moderate, or severe cases.
干预措施: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules (Drug)
Severe Hypophosphatemia Group
Severe hypophosphatemia is defined as a serum phosphate level <0.32 mmol/L. For subjects with severe hypophosphatemia, the phosphorus supplementation dose is 0.816 mmol/(kg·d) based on the subject's actual body weight. During treatment, venous blood is drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the effectiveness of supplementation. The investigator determines the severity of hypophosphatemia based on the day's serum phosphorus level and administers the corresponding phosphorus supplementation dose for mild, moderate, or severe cases.
干预措施: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules (Drug)
结局指标
主要结局
The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period.
时间窗: Within 14 days of study enrollment
Among patients receiving enteral phosphate supplementation during the study period, the proportion achieving the target serum phosphate level (≥0.80 mmol/L). This proportion ranges from 0% to 100%, with a higher value indicating better treatment efficacy of enteral phosphate supplementation.
次要结局
- Changes in APACHE II and SOFA scores from baseline(APACHE II and SOFA scores within 24 hours before the start of the study and within 24 hours before the end of the study)
- The magnitude of serum phosphorus elevation per 1 mmol of enteral phosphorus supplementation in patients during the study period.(The total duration from the start of enteral phosphorus supplementation to the end of phosphorus therapy is less than 14 days.)
- The proportion of patients with a blood phosphorus concentration increase of less than 0.1 mmol/L over any 72-hour period during phosphorus supplementation therapy.(From the initiation of enteral phosphate supplementation to the end of treatment, the increase in serum phosphate levels within any 72-hour period occurs over a total duration of less than 14 days.)
- Incidence of Adverse Reactions(The entire duration of the study, from initiation to completion, shall not exceed 14 days.)
- Proportion of withdrawals due to intolerance to enteral phosphorus supplementation(During the study period, the maximum duration shall not exceed 14 days.)
- Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy(The total duration from the initiation of enteral phosphate supplementation to the normalization of serum phosphate levels is less than 14 days.)
研究者
Wang xiaorong
Internal medicine physician
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology