A Phase 2/3 interventional study of Enema Phosphates Sodium and Glycophos Injectable Product in Acute Hypophosphatemia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
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).
53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.
This study's enrollment of 42 is close to the median of 46 across 26 interventional studies indexed under Hypophosphatemia.
Browse Hypophosphatemia studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
oral diluted phosphate enema
Drug: Enema Phosphates Sodium
intravenous sodium glycerophosphate
Drug: Glycophos Injectable Product
oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.
Also known as: oral diluted phosphate enema
intravenous sodium glycerophosphate as the standard of care or active control
Also known as: intravenous sodium glycerophosphate
efficacy in replacing phosphate
percentage of patients achieving a normal (\>/=2.5mg/dl) or increase in serum level of phosphate
Time frame: 2 days
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
Time frame: 2 days
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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