Acute Hypophosphatemia
Conditions
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).
Interventions
DRUGEnema Phosphates Sodium
oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.
DRUGGlycophos Injectable Product
intravenous sodium glycerophosphate as the standard of care or active control
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy in replacing phosphate | 2 days | percentage of patients achieving a normal (\>/=2.5mg/dl) or increase in serum level of phosphate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of potential side effects | 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 |
Countries
Egypt
Outcome results
None listed