The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphat… (NCT06651892) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.