Mechanical VentilationNCT05682846
Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation
A study testing Sodium glycerophosphate pentahydrate solution in people with Mechanical Ventilation, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Sodium glycerophosphate pentahydrate solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult mechanically ventilated ICU patients.
- Age ≥ 18 years.
Who cannot join
- 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
Show all 9Show fewer
- Cancer patients at risk of tumor lysis syndrome
- Immobility
- Body weight < 50 Kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Serum Phosphorus Level Optimization on Weaning From Mechanical Ventilation in Adult ICU Patients
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.
Read the 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.
- Conditions
- Mechanical Ventilation
- Being tested
- Sodium glycerophosphate pentahydrate solution
- Keywords
- Mechanical ventilation, Phosphorus, Critical illness, Ventilator weaning
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium glycerophosphate pentahydrate solutionDrug
Also called Glycophos
Glycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium glycerophosphate pentahydrate solution |
| Control group | No intervention | Maintaining serum phosphorus level at ≥ 2.5 and < 3.5 mg/dL. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of mechanical ventilation.
Comparison of mechanical ventilation days for patients in the two study groups.
Measured: 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.
Measured: 4 months
Secondary outcomes (3)
Length of ICU stay
Change in the ICU length of stay in the intervention group with respect to the control group
Measured: 4 months
ICU mortality
Change in the ICU mortality in the intervention group with respect to the control group.
Measured: 4 months
Cost effectiveness analysis
Cost-effectiveness analysis of serum phosphorus level optimization.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 May 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Mohamed Mahmoud Abdelghany, Alexandria University
- Investigators
- Magda A El-Massik, PhD, Principal investigator, Professor of Pharmaceutics, Alexandria UniversityHaitham M Tammam, PhD, Principal investigator, Associate professor of Critical Care Medicine, Alexandria UniversityNoha A Hamdy, PhD, Principal investigator, Assistant Professor of Clinical Pharmacy, Alexandria UniversityMarawan M ElBourini, PhD, Principal investigator, Lecturer in Critical Care Medicine, Alexandria UniversityYasmin M Abd Elghany, PharmD, Principal investigator, Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682846
- Sponsor's protocol ID
- 0107114
- Status last verified
- May 2023
- First submitted
- 7 Dec 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3860734World 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.
PubMed 24141714Liu 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.
PubMed 29308755Sin 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.
PubMed 32783487Padelli 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.
PubMed 29089216Sahetya 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.
PubMed 27842754Santibanez-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.
PubMed 33877109Wang 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.
PubMed 31122196Wozniak 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.
PubMed 35160032
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Phosphorus Level Optimization on Weaning From Mechanical Ventilation in Adult ICU Patients
- ClinicalTrials.gov ID
- NCT05682846
- Acronym / sponsor ID
- 0107114
- Conditions
- Mechanical Ventilation
- Keywords
- Mechanical ventilation, Phosphorus, Critical illness, Ventilator weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Sodium glycerophosphate pentahydrate solutionOptimization 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. |
| Control group | No intervention | –Maintaining serum phosphorus level at ≥ 2.5 and < 3.5 mg/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult mechanically ventilated ICU patients.
- Age ≥ 18 years.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium glycerophosphate pentahydrate solutionAlso: GlycophosGlycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml | Drug | Intervention group |
Primary outcome
The duration of mechanical ventilation.
Time frame: 4 months
Comparison of mechanical ventilation days for patients in the two study groups.
Weaning from mechanical ventilation.
Time frame: 4 months
Association of serum phosphorus level optimization to ≥ 3.5 and ≤ 4.5 mg/dL with success of weaning from mechanical ventilation.
3 secondary outcomes
Length of ICU stay
Time frame: 4 months
ICU mortality
Time frame: 4 months
Cost effectiveness analysis
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 3860734Aubier 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.
- Background: PubMed 24141714World 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.
- Background: PubMed 29308755Liu 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.
- Background: PubMed 32783487Sin 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.
- Background: PubMed 29089216Padelli 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.
- Background: PubMed 27842754Sahetya 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.
- Background: PubMed 33877109Santibanez-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.
- Background: PubMed 31122196Wang 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.
- Background: PubMed 35160032Wozniak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda A El-Massik, PhD principal investigator
Professor of Pharmaceutics, Alexandria University
Haitham M Tammam, PhD principal investigator
Associate professor of Critical Care Medicine, Alexandria University
Noha A Hamdy, PhD principal investigator
Assistant Professor of Clinical Pharmacy, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium glycerophosphate pentahydrate solution in people with Mechanical Ventilation, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of mechanical ventilation. (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682846, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.