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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hypophosphatemia Group | Experimental | 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. |
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| Moderate Hypophosphatemia Group | Experimental | 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. |
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| Severe Hypophosphatemia Group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period. | 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. | Within 14 days of study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| The magnitude of serum phosphorus elevation per 1 mmol of enteral phosphorus supplementation in patients during the study period. | 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. | The total duration from the start of enteral phosphorus supplementation to the end of phosphorus therapy is less than 14 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Yu, Ph.D., M.D. | Contact | 86+13971256590 | yuyuanwhuh@hust.edu.cn | |
| Zhuanyun Li, Ph.D., M.D. | Contact | 86+15199108915 | 2577008209@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34705137 | Result | Cheng YC, Beh JY, Wu PH, Tsai NY, Jao SW. Early botulinum toxin injection reduces pain after hemorrhoidectomy: a pilot study. Tech Coloproctol. 2022 Jan;26(1):53-60. doi: 10.1007/s10151-021-02542-4. Epub 2021 Oct 27. | |
| 36065653 | Result | Kaya U, Dal Yilmaz U. Ideal Suggestions for Discharge Training and Telephone Counseling of Patients With Coronary Artery Bypass Graft Surgery: A Randomized Controlled and Experimental Study. J Korean Med Sci. 2022 Sep 5;37(35):e269. doi: 10.3346/jkms.2022.37.e269. |
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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.
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| Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy | Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy. A shorter time indicates better efficacy of phosphorus supplementation. | The total duration from the initiation of enteral phosphate supplementation to the normalization of serum phosphate levels 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. | 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. | 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. |
| Proportion of withdrawals due to intolerance to enteral phosphorus supplementation | Proportion of withdrawals due to intolerance to enteral phosphorus supplementation. A lower withdrawal rate indicates the successful selection of the study population. | During the study period, the maximum duration shall not exceed 14 days. |
| Incidence of Adverse Reactions | The incidence of adverse reactions primarily includes discomfort symptoms such as diarrhea, abdominal pain, nausea, and vomiting. | The entire duration of the study, from initiation to completion, shall not exceed 14 days. |
| Changes in APACHE II and SOFA scores from baseline | 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. | APACHE II and SOFA scores within 24 hours before the start of the study and within 24 hours before the end of the study |
| 22863286 | Result | Felsenfeld AJ, Levine BS. Approach to treatment of hypophosphatemia. Am J Kidney Dis. 2012 Oct;60(4):655-61. doi: 10.1053/j.ajkd.2012.03.024. Epub 2012 Aug 3. |
| 20682049 | Result | Geerse DA, Bindels AJ, Kuiper MA, Roos AN, Spronk PE, Schultz MJ. Treatment of hypophosphatemia in the intensive care unit: a review. Crit Care. 2010;14(4):R147. doi: 10.1186/cc9215. Epub 2010 Aug 3. |
| 38537225 | Result | Nguyen CD, Panganiban HP, Fazio T, Karahalios A, Ankravs MJ, MacIsaac CM, Rechnitzer T, Arno L, Tran-Duy A, McAlister S, Ali Abdelhamid Y, Deane AM. A Randomized Noninferiority Trial to Compare Enteral to Parenteral Phosphate Replacement on Biochemistry, Waste, and Environmental Impact and Healthcare Cost in Critically Ill Patients With Mild to Moderate Hypophosphatemia. Crit Care Med. 2024 Jul 1;52(7):1054-1064. doi: 10.1097/CCM.0000000000006255. Epub 2024 Mar 25. |
| 30569887 | Result | Engwerda E, van den Berg M, Blans M, Bech A, de Boer H. Efficacy and safety of a phosphate replacement strategy for severe hypophosphatemia in the ICU. Neth J Med. 2018 Dec;76(10):437-441. |
| 37042685 | Result | Lair CS, Brown LS, Edwards A, Jacob T, Brion LP, Jaleel M. Quality improvement project in a neonatal intensive care unit reduced the prevalence and duration of hypophosphatemia with significant and sustainable results. Nutr Clin Pract. 2023 Dec;38(6):1379-1391. doi: 10.1002/ncp.10986. Epub 2023 Apr 12. |
| 35511366 | Result | Rubio-Aliaga I, Krapf R. Phosphate intake, hyperphosphatemia, and kidney function. Pflugers Arch. 2022 Aug;474(8):935-947. doi: 10.1007/s00424-022-02691-x. Epub 2022 May 5. |
| 11334065 | Result | Dickerson RN, Gervasio JM, Sherman JJ, Kudsk KA, Hickerson WL, Brown RO. A comparison of renal phosphorus regulation in thermally injured and multiple trauma patients receiving specialized nutrition support. JPEN J Parenter Enteral Nutr. 2001 May-Jun;25(3):152-9. doi: 10.1177/0148607101025003152. |
| 2225887 | Result | Daily WH, Tonnesen AS, Allen SJ. Hypophosphatemia--incidence, etiology, and prevention in the trauma patient. Crit Care Med. 1990 Nov;18(11):1210-4. doi: 10.1097/00003246-199011000-00004. |
| 15296888 | Result | Cohen J, Kogan A, Sahar G, Lev S, Vidne B, Singer P. Hypophosphatemia following open heart surgery: incidence and consequences. Eur J Cardiothorac Surg. 2004 Aug;26(2):306-10. doi: 10.1016/j.ejcts.2004.03.004. |
| 18820097 | Result | Hoffmann M, Zemlin AE, Meyer WP, Erasmus RT. Hypophosphataemia at a large academic hospital in South Africa. J Clin Pathol. 2008 Oct;61(10):1104-7. doi: 10.1136/jcp.2007.054940. |
| ID | Term |
|---|---|
| D017674 | Hypophosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C018279 | sodium phosphate |
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