Comparing phosphate enema to intravenous sodium glycerophosphate for treating low phosphate levels in ICU patients
The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in the Treatment of Hypophosphatemia in ICU Patients
PHASE2; PHASE3 · Ain Shams University · NCT06651892
This study is testing whether a phosphate enema can effectively treat low phosphate levels in critically ill adults compared to the usual intravenous treatment.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Giza) |
| Trial ID | NCT06651892 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of diluted phosphate enemas as a treatment for acute hypophosphatemia in critically ill adults, comparing it to the standard treatment of intravenous sodium glycerophosphate. Participants will be randomly assigned to receive either the phosphate enema or the intravenous treatment, with doses calculated based on their level of hypophosphatemia. The study will assess serum phosphate levels and monitor for any side effects following the interventions. This research addresses the need for alternative treatment options amid shortages of parenteral nutrition solutions.
Who should consider this trial
Good fit: Ideal candidates include critically ill adults aged 18 years or older with mild to moderate hypophosphatemia.
Not a fit: Patients with severe hypophosphatemia or those unable to take oral treatments due to gut integrity issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more accessible treatment option for critically ill patients with low phosphate levels.
How similar studies have performed: While this approach is novel in the context of critically ill patients, similar studies have shown promise in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Giza
- Al haram Hospital — Giza, Egypt (RECRUITING)
Study contacts
- Study coordinator: Hebat allah Najdi, PI
- Email: hebatallah.najdi18@pharma.asu.edu.eg
- Phone: 01004178244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Hypophosphatemia