Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation
NCT ID: NCT05682846
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2022-05-01
2023-02-28
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Sodium glycerophosphate pentahydrate solution
Glycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml
Control group
Maintaining serum phosphorus level at ≥ 2.5 and \< 3.5 mg/dL.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Yasmin Mohamed Mahmoud Abdelghany
Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University
Principal Investigators
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Magda A El-Massik, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Pharmaceutics, Alexandria University
Haitham M Tammam, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate professor of Critical Care Medicine, Alexandria University
Noha A Hamdy, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Clinical Pharmacy, Alexandria University
Marawan M ElBourini, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer in Critical Care Medicine, Alexandria University
Yasmin M Abd Elghany, PharmD
Role: PRINCIPAL_INVESTIGATOR
Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University.
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0107114
Identifier Type: -
Identifier Source: org_study_id
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