Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682846
• Other study ID #: 0107114
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of mechanical ventilation.	Comparison of mechanical ventilation days for patients in the two study groups.	4 months
Primary	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	Length of ICU stay	Change in the ICU length of stay in the intervention group with respect to the control group	4 months
Secondary	ICU mortality	Change in the ICU mortality in the intervention group with respect to the control group.	4 months
Secondary	Cost effectiveness analysis	Cost-effectiveness analysis of serum phosphorus level optimization.	4 months