Al haram Hospital
Giza, Egypt
NCT Number: NCT06651892
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Giza, Egypt
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.
Other names: oral diluted phosphate enema
intravenous sodium glycerophosphate as the standard of care or active control
Other names: intravenous sodium glycerophosphate
Time frame: 2 days
percentage of patients achieving a normal (>/=2.5mg/dl) or increase in serum level of phosphate
Time frame: 2 days
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
Ain Shams University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.