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Completed

NCT Number: NCT05682846

Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

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.

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Key information

Conditions

Mechanical Ventilation Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium glycerophosphate pentahydrate solution

Drug

Glycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml

Other names: Glycophos

Primary outcomes

  1. The duration of mechanical ventilation.

    Time frame: 4 months

    Comparison of mechanical ventilation days for patients in the two study groups.

  2. Weaning from mechanical ventilation.

    Time frame: 4 months

    Association of serum phosphorus level optimization to ≥ 3.5 and ≤ 4.5 mg/dL with success of weaning from mechanical ventilation.

Secondary outcomes

  1. Length of ICU stay

    Time frame: 4 months

    Change in the ICU length of stay in the intervention group with respect to the control group

  2. ICU mortality

    Time frame: 4 months

    Change in the ICU mortality in the intervention group with respect to the control group.

  3. Cost effectiveness analysis

    Time frame: 4 months

    Cost-effectiveness analysis of serum phosphorus level optimization.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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