Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

Not Applicable

Completed

• Conditions: Mechanical Ventilation
• Interventions: Drug: Sodium glycerophosphate pentahydrate solution

• Registration Number: NCT05682846
• Lead Sponsor: Alexandria University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Sodium glycerophosphate pentahydrate solution	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	4 months	Change in the ICU length of stay in the intervention group with respect to the control group
ICU mortality	4 months	Change in the ICU mortality in the intervention group with respect to the control group.
Cost effectiveness analysis	4 months	Cost-effectiveness analysis of serum phosphorus level optimization.

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt