drugset / Trial / NCT06651892

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

NCT06651892 ↗

Phase 2/3 Completed 42 enrolled Ain Shams University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2024-05-01
Primary completion
2024-12-30
Completion
2024-12-30

Outcome

Met primary endpoint

paper CONCLUSION: The oral administration of phosphate enema was found non-inferior to the IV administration of sodium glycerophosphate in treating mild to moderate hypophosphatemia in ICU patients. PMID 41242387 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Enema Phosphates Sodium Unknown 0.32 mmol Oral
Subject Enema Phosphates Sodium Unknown 0.64 mmol Oral
Comparator Glycophos Injectable Product Unknown 0.32 mmol Intravenous
Comparator Glycophos Injectable Product Unknown 0.64 mmol Intravenous

Indications