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Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05682846
Collaborator
(none)
102
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium glycerophosphate pentahydrate solution
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Serum Phosphorus Level Optimization on Weaning From Mechanical Ventilation in Adult ICU Patients
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. The duration of mechanical ventilation. [4 months]

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

    2. 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

    1. Length of ICU stay [4 months]

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

    2. ICU mortality [4 months]

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

    3. Cost effectiveness analysis [4 months]

      Cost-effectiveness analysis of serum phosphorus level optimization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Alexandria Egypt

    Sponsors and Collaborators

    • 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: Noha A Hamdy, PhD, Assistant Professor of Clinical Pharmacy, 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yasmin Mohamed Mahmoud Abdelghany, Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05682846
    Other Study ID Numbers:
    • 0107114
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Yasmin Mohamed Mahmoud Abdelghany, Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University, Alexandria University
    Mechanical ventilation
    Phosphorus
    Critical illness
    Ventilator weaning

    Study Results

    No Results Posted as of Jan 12, 2023