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.

Study Overview

• Status: Completed
• Conditions: Acute Hypophosphatemia
• Intervention / Treatment: Drug: Enema Phosphates Sodium; Drug: Glycophos Injectable Product

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Al haram Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - oral diluted phosphate enema; oral diluted phosphate enema	Drug: Enema Phosphates Sodium; 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
Active Comparator: Group B - intravenous sodium glycerophosphate; intravenous sodium glycerophosphate	Drug: Glycophos Injectable Product; intravenous sodium glycerophosphate as the standard of care or active control; Other Names: intravenous sodium glycerophosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy in replacing phosphate	percentage of patients achieving a normal (>/=2.5mg/dl) or increase in serum level of phosphate	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of potential side effects	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	2 days

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 15, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hypophosphatemia
• Other Study ID Numbers: REC #270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No