CompletedPhase 2/3

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

Egypt42 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Critically ill Patients with mild (2-2.4 mg/dl) to moderate (1.5-1.9 mg/dl) hypophosphatemia. * Serum phosphorus level less than 2.5mg/dl - between 1.5 - 2.5mg/dl * Patients 18 years or older Exclusion Criteria: * Severe hypophosphatemia * Serum Phosphorus level less than 1.5 mg/dL * Patients on Non-peroral status * Ileus (as paralytic ileus, post-operative) * Any problem in gut integrity as (intestinal obstruction, Severe Malabsorption, severe diarrhea) * Any form of ischemic gut (as mesenteric ischemia, mesenteric gastric occlusion, arterial venous insufficiency) * Hemodynamically unstable patients * Severe Hypocalcemia or Hypercalcemia at the beginning of the study (when iv phosphate is deemed inappropriate at the discretion of attending physician)

What they're measuring

efficacy in replacing phosphate

Timeframe: 2 days

Trial details

NCT IDNCT06651892

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30