Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

May 17, 2023 updated by: Yasmin Mohamed Mahmoud Abdelghany, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

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
Glycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml
Other Names:
  • Glycophos
No Intervention: Control group
Maintaining serum phosphorus level at ≥ 2.5 and < 3.5 mg/dL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of mechanical ventilation.
Time Frame: 4 months
Comparison of mechanical ventilation days for patients in the two study groups.
4 months
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.
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Magda A El-Massik, PhD, Professor of Pharmaceutics, Alexandria University
  • Principal Investigator: Haitham M Tammam, PhD, Associate professor of Critical Care Medicine, Alexandria University
  • Principal Investigator: Marawan M ElBourini, PhD, Lecturer in Critical Care Medicine, Alexandria University
  • Principal Investigator: Yasmin M Abd Elghany, PharmD, Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University.
  • Principal Investigator: Noha A Hamdy, PhD, Assistant Professor of Clinical Pharmacy, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0107114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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