Phosphate DeficiencyNCT04800770
The Effect of COVID-19 Patients' Serum Phosphate Level on Mortality in ICU
An observational study of Phosphate Deficiency and Covid19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to investigate the relationship between phosphate level and mortality using the 4C Mortality Score in COVID-19 patients who were followed up in the intensive care unit. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Phosphate Deficiency, Covid19, Mortality
- What is being tested?
- 4C mortality score
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2021to 31 Jul 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study
Who may be able to join
- Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study
Who cannot join
- there is no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06800
İsmail Aytac, +905056340369, aytacismail1972@gmail.com
About this study
Official title: Phosphate Levels of COVID-19 Patients and Mortality
The investigators aimed to investigate the relationship between phosphate level and mortality using the 4C Mortality Score in COVID-19 patients who were followed up in the intensive care unit.
- Conditions
- Phosphate Deficiency, Covid19, Mortality
- Being tested
- 4C mortality score
- Keywords
- COVID19, phosphate deficiency, 4C mortality score
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4C mortality scoreDiagnostic test
4C mortality score and phosphate levels
What is being measured
The primary outcome is the main question the study is designed to answer.
4C mortality score
4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters
Measured: 6 months
serum phosphate levels
mg/dl
Measured: 6 months
mortality
mortality percentage of patients in 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start3 Mar 2021
- Primary completion15 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Phosphate DeficiencyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- betül aytaç, MD, Principal investigator, ankara ch bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800770
- Sponsor's protocol ID
- E1-21-1584
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murer H, Forster I, Biber J. The sodium phosphate cotransporter family SLC34. Pflugers Arch. 2004 Feb;447(5):763-7. doi: 10.1007/s00424-003-1072-5. Epub 2003 May 16.
PubMed 12750889Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
PubMed 28219057Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphate Levels of COVID-19 Patients and Mortality
- ClinicalTrials.gov ID
- NCT04800770
- Acronym / sponsor ID
- E1-21-1584
- Conditions
- Phosphate Deficiency, Covid19, Mortality
- Keywords
- COVID19, phosphate deficiency, 4C mortality score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 16 Mar 2021 (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 investigators aimed to investigate the relationship between phosphate level and mortality using the 4C Mortality Score in COVID-19 patients who were followed up in the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study
Key inclusion criteria (1 listed)
- Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study
Key exclusion criteria (1 listed)
- there is no exclusion criteria
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 |
|---|---|---|
| 4C mortality score4C mortality score and phosphate levels | Diagnostic test | – |
Primary outcome
4C mortality score
Time frame: 6 months
4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters
serum phosphate levels
Time frame: 6 months
mg/dl
mortality
Time frame: 28 days
mortality percentage of patients in 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Results publication: PubMed 12750889Murer H, Forster I, Biber J. The sodium phosphate cotransporter family SLC34. Pflugers Arch. 2004 Feb;447(5):763-7. doi: 10.1007/s00424-003-1072-5. Epub 2003 May 16.
- Results publication: PubMed 28219057Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
- Results publication: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Individual participant dataSharing planned: Undecided
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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.
betül aytaç, MD principal investigator
ankara ch bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phosphate Deficiency and Covid19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact betül aytaç, MD (+905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4C mortality score (time frame: 6 months). The study lists 3 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 NCT04800770, which also lists 3 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 16 Mar 2021.