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Publications

Journal Article Ahead of print

PubMed: 41242387 DOI: 10.1016/j.clnesp.2025.11.015

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

Authors: Heba Najdi, Rana Sayed, Ahmed Sayed Mettawi, Manal El-Hamamsy

Affiliations

  • Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
  • Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
  • clinical nutrition department, Al-Haram specialized hospital, Cairo, Egypt.

Abstract

BACKGROUND AND AIM

The management of hypophosphatemia in critically-ill patients remains a clinical challenge due to the lack of clear guidelines and the reliance on intravenous (IV) phosphate preparations, which carry risks of serious electrolyte disturbances and are affected by global shortages. These limitations hinder effective treatment and may increase mortality risk in this vulnerable population. Phosphate enemas may offer a viable alternative, particularly in resource-limited settings. This study aimed to assess the efficacy and safety of diluted oral phosphate enema in managing mild to moderate hypophosphatemia in critically-ill patients compared to IV sodium glycerophosphate.

METHODS

A randomized controlled prospective non-inferiority trial was conducted on critically-ill patients diagnosed with mild to moderate hypophosphatemia in the general medical intensive care unit (ICU). Patients were randomized into two parallel groups, intervention group received oral diluted phosphate enema while control group received IV sodium glycerophosphate. Patients were followed-up for 48 hours to test the efficacy of each drug to normalize serum phosphate level, as well as their potential for adverse events.

RESULTS

Forty-two eligible ICU patients entered the study and were randomized to both groups in a 1:1 ratio. 71.4% of patients receiving diluted oral phosphate enema achieved normal phosphate level, while 42.8% of patients receiving IV sodium glycerophosphate achieved normal phosphate level with one patient in the control group developing hyperphosphatemia. Regarding safety profile, there were no significant differences between both groups for the occurrence of new onset diarrhea (p = 0.634), vomiting (p < 0.99), or hypernatremia (p = 0.569).

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.

GOV IDENTIFIER

NCT06651892 TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06651892Date of Registration: May 2024Public URL: https://trial.medpath.com/clinical-trial/3fe4c86f4058d739/nct06651892-oral-phosphate-enema-vs-sodium-glycerophosphate-hypophosphatemia.

MeSH

Safety, Hypophosphatemia, Enema, Therapeutics, Intensive Care Units, Glycerophosphates