Clinical nutrition ESPEN · 2025
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.
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Najdi Heba, Sayed Rana, Mettawi Ahmed Sayed, El-Hamamsy Manal
Аннотация
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 h 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: Date of Registration: May 2024 Public URL: https://trial.medpath.com/clinical-trial/3fe4c86f4058d739/nct06651892-oral-phosphate-enema-vs-sodium-glycerophosphate-hypophosphatemia.
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 h 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: Date of Registration: May 2024 Public URL: https://trial.medpath.com/clinical-trial/3fe4c86f4058d739/nct06651892-oral-phosphate-enema-vs-sodium-glycerophosphate-hypophosphatemia.