NCT05682846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

December 7, 2022

Last Update Submit

May 17, 2023

Conditions

Mechanical Ventilation

Keywords

Mechanical ventilationPhosphorusCritical illnessVentilator weaning

Outcome Measures

Primary Outcomes (2)

  • The duration of mechanical ventilation.

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

    4 months

  • Weaning from mechanical ventilation.

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

    4 months

Secondary Outcomes (3)

  • Length of ICU stay

    4 months

  • ICU mortality

    4 months

  • Cost effectiveness analysis

    4 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Sodium glycerophosphate pentahydrate solutionDRUG

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

Also known as: Glycophos
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult mechanically ventilated ICU patients.
  • Age ≥ 18 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (9)

  • Aubier M, Murciano D, Lecocguic Y, Viires N, Jacquens Y, Squara P, Pariente R. Effect of hypophosphatemia on diaphragmatic contractility in patients with acute respiratory failure. N Engl J Med. 1985 Aug 15;313(7):420-4. doi: 10.1056/NEJM198508153130705.

    PMID: 3860734BACKGROUND

  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

    PMID: 24141714BACKGROUND

  • Liu B, Cheng Y, Shen F, Wang Y, Wu Y, Yao L, Liu Y, Gou X. [Hypophosphatemia is associated with poor prognosis of critically ill patients: a meta-analysis of 1 555 patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Jan;30(1):34-40. doi: 10.3760/cma.j.issn.2095-4352.2018.01.007. Chinese.

    PMID: 29308755BACKGROUND

  • Sin JCK, King L, Ballard E, Llewellyn S, Laupland KB, Tabah A. Hypophosphatemia and Outcomes in ICU: A Systematic Review and Meta-Analysis. J Intensive Care Med. 2021 Sep;36(9):1025-1035. doi: 10.1177/0885066620940274. Epub 2020 Aug 12.

    PMID: 32783487BACKGROUND

  • Padelli M, Leven C, Sakka M, Plee-Gautier E, Carre JL. [Causes, consequences and treatment of hypophosphatemia: A systematic review]. Presse Med. 2017 Nov;46(11):987-999. doi: 10.1016/j.lpm.2017.09.002. Epub 2017 Oct 28. French.

    PMID: 29089216BACKGROUND

  • Sahetya S, Allgood S, Gay PC, Lechtzin N. Long-Term Mechanical Ventilation. Clin Chest Med. 2016 Dec;37(4):753-763. doi: 10.1016/j.ccm.2016.07.014. Epub 2016 Oct 14.

    PMID: 27842754BACKGROUND

  • Santibanez-Velazquez M, Medina-Garcia G, Ocharan-Hernandez ME. Association of independent risk factors with post-extubation failure in patients undergoing mechanical ventilation weaning. Gac Med Mex. 2020;156(6):539-545. doi: 10.24875/GMM.M21000493.

    PMID: 33877109BACKGROUND

  • Wang L, Xiao C, Chen L, Zhang X, Kou Q. Impact of hypophosphatemia on outcome of patients in intensive care unit: a retrospective cohort study. BMC Anesthesiol. 2019 May 24;19(1):86. doi: 10.1186/s12871-019-0746-2.

    PMID: 31122196BACKGROUND

  • Wozniak H, Dos Santos Rocha A, Beckmann TS, Larpin C, Buetti N, Quintard H, Pugin J, Heidegger CP. Hypophosphatemia on ICU Admission Is Associated with an Increased Length of Stay in the ICU and Time under Mechanical Ventilation. J Clin Med. 2022 Jan 24;11(3):581. doi: 10.3390/jcm11030581.

    PMID: 35160032BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 12, 2023

Study Start

May 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)