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Completed

NCT Number: NCT06651892

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Al haram Hospital

Giza, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enema Phosphates Sodium

Drug

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

Glycophos Injectable Product

Drug

intravenous sodium glycerophosphate as the standard of care or active control

Other names: intravenous sodium glycerophosphate

Primary outcomes

  1. efficacy in replacing phosphate

    Time frame: 2 days

    percentage of patients achieving a normal (>/=2.5mg/dl) or increase in serum level of phosphate

Secondary outcomes

  1. occurrence of potential side effects

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.