Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651892
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-12
Brief Title:
The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in the Treatment of Hypophosphatemia in ICU Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in the Treatment of Hypophosphatemia in ICU Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 referenceCrook 2009 032 mmol per kg for mild hypophosphatemia 064 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
Dose Calculation as per hospital protocol and scientific referenceCrook 2009 032 mmol per kg for mild hypophosphatemia 064 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None