Clinical trial NCT05682846: Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation
Official title: Impact of Serum Phosphorus Level Optimization on Weaning From Mechanical Ventilation in Adult ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Mechanical ventilation
Phosphorus
Critical illness
Ventilator weaning
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The duration of mechanical ventilation.
timeFrame: 4 months
measure: Weaning from mechanical ventilation.
timeFrame: 4 months
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 4 months
measure: ICU mortality
timeFrame: 4 months
measure: Cost effectiveness analysis
timeFrame: 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Professor of Pharmaceutics, Alexandria University
name: Magda A El-Massik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate professor of Critical Care Medicine, Alexandria University
name: Haitham M Tammam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor of Clinical Pharmacy, Alexandria University
name: Noha A Hamdy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer in Critical Care Medicine, Alexandria University
name: Marawan M ElBourini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University.
name: Yasmin M Abd Elghany, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.