Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

Alexandria University

Status: Completed

Conditions: Mechanical Ventilation

Treatments: Drug: Sodium glycerophosphate pentahydrate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05682846

0107114

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Drug: Sodium glycerophosphate pentahydrate solution

Control group

No Intervention group

Description:

Maintaining serum phosphorus level at ≥ 2.5 and \< 3.5 mg/dL.