Magnesium DisorderNCT05903677
The Relationship Between Preoperative Levels of Ionized Magnesium and Risk of Acute Kidney Injury After Cardiac Surgery
An observational study of Magnesium Disorder, run by Assiut University.
Trial summary
Detection the relationship between preoperative ionized magnesium levels and the risk of acute kidney injury after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnesium Disorder
- What is being tested?
- magnesium levels
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: people more than or equal 18 years who undergo open heart surgery between July 2023 to July 2024 and not known to have kidney disease .
Who may be able to join
- patients more than or equal 18 yrs.
- patients undergoing cardiac surgery between July 2023 and July 2024
Who cannot join
- patients with known Kidney disease.
- patients less than 18 yrs
Trial locations and contacts
No sites are listed yet.
About this study
Detection the relationship between preoperative ionized magnesium levels and the risk of acute kidney injury after cardiac surgery.
Read the detailed description
Acute kidney injury (AKI) is a major medical problem that is of particular concern after cardiac surgery. The reported prevalence of cardiac surgery-associated acute kidney injury (CSA-AKI) is up to 30% and is independently associated with an increase of morbidity and mortality .So this study is for measuring preoperative ionized magnesium levels of patients who will undergo cardiac surgeries then measuring postoperative serum creatinine, BUN and urine output to detect if they developed AKI or not and if there is a relationship between the post cardiac surgery AKI and preoperative ionized magnesium levels.
- Conditions
- Magnesium Disorder
- Being tested
- magnesium levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium levelsOther
Also called Serum creatinine and blood urea nitrogen (BUN)
Detection of the relationship between cardiac surgery associated AKI and preoperative magnesium levels.
| Study group | Role | What they receive |
|---|---|---|
| Adults undergoing cardiac surgery without preoperative renal affection | Detect the preoperative magnesium levels in adults undergoing cardiac surgery without preoperative renal affection and follow up if they developed postoperative acute kidney injury or not. Receives: Other: magnesium levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post cardiac surgery AKI according to KDIGO criteria with low preoperative magnesium level
Measuring preoperative magnesium level and postoperative kidney functions in form of serum creatinine in umol/L , BUN in mmol/L and urine output ml/h to detect the relationship between preoperative low magnesium level and risk of acute kidney injury after cardiac surgery.
Measured: Baseline
Post cardiac surgery AKI according to KDIGO criteria with normal or high preoperative magnesium level
Measuring preoperative magnesium level and postoperative serum creatinine, BUN and urine output to detect the relationship between preoperative magnesium level and risk of acute kidney injury after cardiac surgery.
Measured: basline
Post cardiac surgery normal kidney functions with low preoperative magnesium level
Measuring preoperative magnesium level and postoperative serum creatinine, BUN and urine output to detect the relationship between preoperative magnesium level and risk of acute kidney injury after cardiac surgery.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnesium DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Kaleed Abdelhalim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903677
- Sponsor's protocol ID
- Preoperative magnesium and AKI
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koh HB, Jung CY, Kim HW, Kwon JY, Kim NH, Kim HJ, Jhee JH, Han SH, Yoo TH, Kang SW, Park JT. Preoperative Ionized Magnesium Levels and Risk of Acute Kidney Injury After Cardiac Surgery. Am J Kidney Dis. 2022 Nov;80(5):629-637.e1. doi: 10.1053/j.ajkd.2022.03.004. Epub 2022 Apr 23.
PubMed 35469966
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Preoperative Levels of Ionized Magnesium and Risk of Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05903677
- Acronym / sponsor ID
- Preoperative magnesium and AKI
- Conditions
- Magnesium Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Jun 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.
Detection the relationship between preoperative ionized magnesium levels and the risk of acute kidney injury after cardiac surgery.
Detailed description
Acute kidney injury (AKI) is a major medical problem that is of particular concern after cardiac surgery. The reported prevalence of cardiac surgery-associated acute kidney injury (CSA-AKI) is up to 30% and is independently associated with an increase of morbidity and mortality .So this study is for measuring preoperative ionized magnesium levels of patients who will undergo cardiac surgeries then measuring postoperative serum creatinine, BUN and urine output to detect if they developed AKI or not and if there is a relationship between the post cardiac surgery AKI and preoperative ionized magnesium levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults undergoing cardiac surgery without preoperative renal affection | – | Other: magnesium levelsDetect the preoperative magnesium levels in adults undergoing cardiac surgery without preoperative renal affection and follow up if they developed postoperative acute kidney injury or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- people more than or equal 18 years who undergo open heart surgery between July 2023 to July 2024 and not known to have kidney disease .
Key inclusion criteria (2 listed)
- patients more than or equal 18 yrs.
- patients undergoing cardiac surgery between July 2023 and July 2024
Key exclusion criteria (2 listed)
- patients with known Kidney disease.
- patients less than 18 yrs
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 |
|---|---|---|
| magnesium levelsAlso: Serum creatinine and blood urea nitrogen (BUN)Detection of the relationship between cardiac surgery associated AKI and preoperative magnesium levels. | Other | Adults undergoing cardiac surgery without preoperative renal affection |
Primary outcome
Post cardiac surgery AKI according to KDIGO criteria with low preoperative magnesium level
Time frame: Baseline
Measuring preoperative magnesium level and postoperative kidney functions in form of serum creatinine in umol/L , BUN in mmol/L and urine output ml/h to detect the relationship between preoperative low magnesium level and risk of acute kidney injury after cardiac surgery.
Post cardiac surgery AKI according to KDIGO criteria with normal or high preoperative magnesium level
Time frame: basline
Measuring preoperative magnesium level and postoperative serum creatinine, BUN and urine output to detect the relationship between preoperative magnesium level and risk of acute kidney injury after cardiac surgery.
Post cardiac surgery normal kidney functions with low preoperative magnesium level
Time frame: basline
Measuring preoperative magnesium level and postoperative serum creatinine, BUN and urine output to detect the relationship between preoperative magnesium level and risk of acute kidney injury after cardiac surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 35469966Koh HB, Jung CY, Kim HW, Kwon JY, Kim NH, Kim HJ, Jhee JH, Han SH, Yoo TH, Kang SW, Park JT. Preoperative Ionized Magnesium Levels and Risk of Acute Kidney Injury After Cardiac Surgery. Am J Kidney Dis. 2022 Nov;80(5):629-637.e1. doi: 10.1053/j.ajkd.2022.03.004. Epub 2022 Apr 23.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnesium Disorder, run by Assiut University.
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 2 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mostafa Ahmed (01113038074, mostafakaleed21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post cardiac surgery AKI according to KDIGO criteria with low preoperative magnesium level (time frame: Baseline). 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 NCT05903677, which also lists 1 linked publication.
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 15 Jun 2023.