Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to study the efficacy and safety of diluted phosphate enema in treating hypophosphatemia in adults in critical care unit in comparison to intravenous sodium glycero-phosphate as the current standard of care.
The main question it aims to answer is:
can the investigators rely on phosphate enemas as an effective and safe treatment option for hypophosphatemia in critically ill adults, in the era of global shortage of parenteral nutrition solutions and the absence of defined guidelines for treatment of acute hypophosphatemia in those population.
A Randomized Controlled Trial - Non inferiority trial of 2 groups, Eligible participants will be randomly assigned to one of two groups (Intervention Group will receive Diluted Oral phosphate enema as the repletion strategy, while Control Group will receive The Standard of care: intravenous sodium glycerophosphate) for the purpose of treatment of hypophosphatemia in critically ill patients.
Dose Calculation: as per hospital protocol and scientific reference(Crook, 2009) 0.32 mmol per kg for mild hypophosphatemia 0.64 mmol per kg for moderate hypophosphatemia
All participants will be reassessed the next day after the intervention and followed up for the occurrence of any side effects, then participants will be followed up again the day after. (Assessment of serum phosphate and sodium along with occurrence of diarrhea or any other side effects).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - oral diluted phosphate enema | Experimental | oral diluted phosphate enema |
|
| Group B - intravenous sodium glycerophosphate | Active Comparator | intravenous sodium glycerophosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enema Phosphates Sodium | Drug | oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy in replacing phosphate | percentage of patients achieving a normal (>/=2.5mg/dl) or increase in serum level of phosphate | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of potential side effects | Monitoring of Clinical complications of phosphate replacement like diarrhea, measured as Number of events (watery diarrhea) > 3 times/day, and New Onset of Hypocalcemia /Hypercalcemia or Hypernatremia | 2 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al haram Hospital | Giza | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41242387 | Derived | Najdi H, Sayed R, Mettawi AS, El-Hamamsy M. The efficacy and safety of diluted oral phosphate enema versus intravenous sodium glycerophosphate in the treatment of hypophosphatemia in intensive care unit patients - A non-inferiority trial. Clin Nutr ESPEN. 2025 Dec;70:692-700. doi: 10.1016/j.clnesp.2025.11.015. Epub 2025 Nov 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Glycophos Injectable Product | Drug | intravenous sodium glycerophosphate as the standard of care or active control |
|
|