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

NCT ID: NCT06651892

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-30

Brief 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.

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).

Conditions

Acute Hypophosphatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A - oral diluted phosphate enema

oral diluted phosphate enema

Group Type: EXPERIMENTAL

Enema Phosphates Sodium

Intervention Type: DRUG

oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.

Group B - intravenous sodium glycerophosphate

intravenous sodium glycerophosphate

Group Type: ACTIVE_COMPARATOR

Glycophos Injectable Product

Intervention Type: DRUG

intravenous sodium glycerophosphate as the standard of care or active control

Interventions

Enema Phosphates Sodium

oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.

Intervention Type: DRUG

Glycophos Injectable Product

intravenous sodium glycerophosphate as the standard of care or active control

Intervention Type: DRUG

Other Intervention Names

oral diluted phosphate enema; intravenous sodium glycerophosphate

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Al haram Hospital

Giza, , Egypt

Countries

Egypt

Other Identifiers

REC #270

Identifier Type: -

Identifier Source: org_study_id