NCT06651892

The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in The Treatment of Hypophosphatemia in ICU Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Acute Hypophosphatemia

Interventions

Type	Name	Description
DRUG	Enema Phosphates Sodium	oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.
DRUG	Glycophos Injectable Product	intravenous sodium glycerophosphate as the standard of care or active control

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-10-22
• Last updated: 2025-06-18

Locations

1 site across 1 country: Egypt