Hypophosphatemia
Conditions
Keywords
Hypophosphatemia, Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
Brief summary
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.
Interventions
DRUGSodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
After signing the informed consent form (ICF), eligible subjects were stratified based on the severity of hypophosphatemia during the screening period: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), or severe hypophosphatemia (\<0.32 mmol/L). Following enrollment, subjects entered a treatment period of up to 14 days. All subjects received a differentiated phosphate supplementation strategy based on actual body weight: subjects with mild hypophosphatemia received 0.306 mmol/(kg·d); those with moderate hypophosphatemia received 0.612 mmol/(kg·d); and those with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood was drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the efficacy of supplementation. Based on the daily serum phosphorus level, the investigator determined the severity of hypophosphatemia and administered the corresponding phosphate dose.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
All participants with hypophosphatemia were enrolled in this study and stratified according to the severity of hypophosphatemia: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), and severe hypophosphatemia (\<0.32 mmol/L). All subjects received differentiated phosphorus supplementation strategies: subjects with mild hypophosphatemia were administered 0.306 mmol/(kg·d); subjects with moderate hypophosphatemia received 0.612 mmol/(kg·d); and subjects with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood samples were collected from subjects to measure blood phosphorus levels to evaluate the effect of phosphorus supplementation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-80 years (inclusive), regardless of gender; 2. ICU inpatients with a serum phosphate concentration \<0.80 mmol/L, and for whom the clinician determines phosphate supplementation is required; 3. Ability to receive enteral nutrition, with a daily enteral caloric intake ≥10 kcal/kg/day; 4. 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.
Exclusion criteria
1. Pregnant and lactating women; 2. 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; 3. Expected ICU stay ≤96 hours; 4. Known allergy to any component of the investigational drug or drugs with a similar chemical structure; 5. Severe renal impairment: estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m²; 6. Subjects with hyperthyroidism requiring clinical intervention; 7. Subjects requiring sodium restriction; 8. Other conditions deemed by the investigator as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy. A shorter time indicates better efficacy of phosphorus supplementation. |
| 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. | 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. This proportion reflects the efficacy of phosphorus replacement therapy, with a higher proportion indicating poorer treatment response in more patients. |
| 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 magnitude of serum phosphorus elevation per 1 mmol of enteral phosphorus supplementation in patients during the study period. A greater magnitude of serum phosphorus elevation indicates better treatment efficacy of phosphorus supplementation. |
| Incidence of Adverse Reactions | The entire duration of the study, from initiation to completion, shall not exceed 14 days. | The incidence of adverse reactions primarily includes discomfort symptoms such as diarrhea, abdominal pain, nausea, and vomiting. |
| 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 | Changes from baseline in the Acute Physiology and Chronic Health Evaluation (APACHE II) score and Sequential Organ Failure Assessment (SOFA) score. The APACHE II score ranges from 0 to 71 points, with higher scores indicating greater mortality risk. The SOFA score ranges from 0 to 24 points, where higher scores reflect more severe organ dysfunction and indicate a more critical patient condition. |
| Proportion of withdrawals due to intolerance to enteral phosphorus supplementation | During the study period, the maximum duration shall not exceed 14 days. | Proportion of withdrawals due to intolerance to enteral phosphorus supplementation. A lower withdrawal rate indicates the successful selection of the study population. |
Countries
China
Contacts
Primary ContactYuan Yu, Ph.D., M.D.
Backup ContactZhuanyun Li, Ph.D., M.D.
Outcome results
None listed