Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the impact of serum phosphorus level optimization on weaning from mechanical ventilation in adult ICU patients in Alexandria University Hospitals. The main questions it aims to answer are: Does serum phosphorus level optimization affect the duration of mechanical ventilation? Is serum phosphorus level optimization associated with successful weaning from mechanical ventilation? In critically ill patients, phosphorus supplementation is done using Sodium glycerophosphate pentahydrate solution.

Detailed Description
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Investigators will document patients' data in terms of independent variables and will randomly allocate the participants into one of the two study groups mentioned below. Control group, defined by maintaining serum phosphorus level at ≥ 2.5 and < 3.5 mg/dL. Intervention group, defined by optimization of serum phosphorus P to ≥ 3.5 and ≤ 4.5 mg/dL (Average 4mg/dL). Regression and comparative statistics will be used to determine whether the optimum serum phosphorus level offers a benefit in terms of the duration of mechanical ventilation and the success of weaning from mechanical ventilation.

Official Title
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Impact of Serum Phosphorus Level Optimization on Weaning From Mechanical Ventilation in Adult ICU Patients

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Drug: Sodium glycerophosphate pentahydrate solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult mechanically ventilated ICU patients. Age ≥ 18 years. Exclusion Criteria: Age <18 years Hypernatremia Permanent or prolonged mechanical ventilation Hyperphosphatemia which might occur in the following conditions: Chronic kidney disease and end stage renal disease Parathyroid disorders Cancer patients at risk of tumor lysis syndrome Immobility Body weight < 50 Kg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Optimization of serum phosphorus to ≥ 3.5 and ≤ 4.5 mg/dL (Average 4mg/dL) using Sodium glycerophosphate pentahydrate solution. Sodium glycerophosphate pentahydrate 20ml solution (20 mmol glycerophosphate) dose will be given once daily till the target serum phosphorus level is achieved. | Drug: Sodium glycerophosphate pentahydrate solution<br>* Glycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml<br>* Other names: Glycophos;|
| No Intervention: Control group<br>Maintaining serum phosphorus level at ≥ 2.5 and < 3.5 mg/dL. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of mechanical ventilation. | Comparison of mechanical ventilation days for patients in the two study groups. | 4 months | 
| Weaning from mechanical ventilation. | Association of serum phosphorus level optimization to ≥ 3.5 and ≤ 4.5 mg/dL with success of weaning from mechanical ventilation. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay | Change in the ICU length of stay in the intervention group with respect to the control group | 4 months | 
| ICU mortality | Change in the ICU mortality in the intervention group with respect to the control group. | 4 months | 
| Cost effectiveness analysis | Cost-effectiveness analysis of serum phosphorus level optimization. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Phosphorus, Critical illness, Ventilator weaning