Acute Kidney InjuryNCT05548725
Relation Between Acute Kidney Injury and Mineral Bone Disease
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
Relation between acute kidney injury and mineral bone disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Reguired field
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2022to Oct 2023
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: c. Sample Size Calculation: 200 cases , 200 controls from December 2021to December 2023 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Study techniques: a) Full (thorough) history \& clinical examination. b) Laboratory investigations: * Blood Urea, Serum creatinine * Pth * Ph * Ca * Na * k * Mg * Vit d * Other routine investigations c) Imaging: * Abdominal U/S d) ECG 2.4.5 -Research outcome measures: a. Primary (main): * Identify the association between Acut
Who may be able to join
- 200 patients with acute kidney injury and their relationship to mineral bone disease.
Who cannot join
- Non hypertensive
- Non cardiac
- Active malignancy
- Acute or chronic liver disease
- Acute poisoning
- Covid
Trial locations and contacts
No sites are listed yet.
About this study
Relation between acute kidney injury and mineral bone disease
Read the detailed description
Assiut Medical School Research Proposal Form 2 Part 2: Research Details 2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work).
Numerous studies have evaluated the prevalence and importance of mineral and bone disorders among patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). However, little is known about dysregulated mineral and bone metabolism in acute kidney injury (AKI) [ Acute kidney injury is the new consensus term for acute renal failure It refers to a clinical syndrome characterised by a rapid (hours to days) decrease in renal excretory function, with the accumulation of products of nitrogen metabolism such as creatinine and urea and other clinically unmeasured waste products. Other common clinical and laboratory manifestations include decreased urine output (not always present), accumulation of metabolic acids, and increased potassium and phosphate concentrations. The term acute kidney injury has replaced acute renal failure to emphasise that a continuum of kidney injury exists that begins long before sufficient loss of excretory kidney function can be measured with standard laboratory tests. The term also suggests a continuum of prognosis, with increasing mortality associated with even small rises in serum creatinine, and additional increases in mortality as creatinine concentration rises. The incidence of acute kidney injury (AKI) is increasing among hospitalized patients . Treating the condition consumes significant amounts of resources even after hospital discharge
. Although AKI was once considered a reversible condition, mounting evidence has indicated that AKI may have a negative impact upon subsequent renal function and long-term prognosis, even if kidney
- Conditions
- Acute Kidney Injury
- Being tested
- Reguired field
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reguired fieldOther
Investigations to know relationship between acute kidney injury and mineral bone disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between AKI and mineral bone disease
Relationship between acute kidney injury and mineral bone disease
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start25 Sep 2022 (estimated)
- Primary completion25 Sep 2023 (estimated)
- Study completionOct 2023 (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 Acute Kidney InjuryStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ahmed Mohamed Abd Elraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548725
- Sponsor's protocol ID
- Relation between AKI and BMD
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agar A, Gulabi D, Sahin A, Gunes O, Hancerli CO, Kilic B, Erturk C. Acute kidney injury after hip fracture surgery in patients over 80 years of age. Arch Orthop Trauma Surg. 2022 Sep;142(9):2245-2252. doi: 10.1007/s00402-021-03969-y. Epub 2021 May 31.
PubMed 34056678Koizumi M, Komaba H, Fukagawa M. Parathyroid function in chronic kidney disease: role of FGF23-Klotho axis. Contrib Nephrol. 2013;180:110-23. doi: 10.1159/000346791. Epub 2013 May 3.
PubMed 23652554Wesseling-Perry K, Salusky IB. Phosphate binders, vitamin D and calcimimetics in the management of chronic kidney disease-mineral bone disorders (CKD-MBD) in children. Pediatr Nephrol. 2013 Apr;28(4):617-25. doi: 10.1007/s00467-012-2381-8. Epub 2013 Feb 5.
PubMed 23381010
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Acute Kidney Injury and Mineral Bone Disease
- ClinicalTrials.gov ID
- NCT05548725
- Acronym / sponsor ID
- Relation between AKI and BMD
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- 25 Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 21 Sep 2022 (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.
Relation between acute kidney injury and mineral bone disease
Detailed description
Assiut Medical School Research Proposal Form 2 Part 2: Research Details 2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work).
Numerous studies have evaluated the prevalence and importance of mineral and bone disorders among patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). However, little is known about dysregulated mineral and bone metabolism in acute kidney injury (AKI) [ Acute kidney injury is the new consensus term for acute renal failure It refers to a clinical syndrome characterised by a rapid (hours to days) decrease in renal excretory function, with the accumulation of products of nitrogen metabolism such as creatinine and urea and other clinically unmeasured waste products. Other common clinical and laboratory manifestations include decreased urine output (not always present), accumulation of metabolic acids, and increased potassium and phosphate concentrations. The term acute kidney injury has replaced acute renal failure to emphasise that a continuum of kidney injury exists that begins long before sufficient loss of excretory kidney function can be measured with standard laboratory tests. The term also suggests a continuum of prognosis, with increasing mortality associated with even small rises in serum creatinine, and additional increases in mortality as creatinine concentration rises. The incidence of acute kidney injury (AKI) is increasing among hospitalized patients . Treating the condition consumes significant amounts of resources even after hospital discharge
. Although AKI was once considered a reversible condition, mounting evidence has indicated that AKI may have a negative impact upon subsequent renal function and long-term prognosis, even if kidney
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- c. Sample Size Calculation: 200 cases , 200 controls from December 2021to December 2023 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Study techniques: a) Full (thorough) history \& clinical examination. b) Laboratory investigations: * Blood Urea, Serum creatinine * Pth * Ph * Ca * Na * k * Mg * Vit d * Other routine investigations c) Imaging: * Abdominal U/S d) ECG 2.4.5 -Research outcome measures: a. Primary (main): * Identify the association between Acut
Key inclusion criteria (1 listed)
- 200 patients with acute kidney injury and their relationship to mineral bone disease.
Key exclusion criteria (6 listed)
- Non hypertensive
- Non cardiac
- Active malignancy
- Acute or chronic liver disease
- Acute poisoning
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 |
|---|---|---|
| Reguired fieldInvestigations to know relationship between acute kidney injury and mineral bone disease | Other | – |
Primary outcome
Relation between AKI and mineral bone disease
Time frame: Baseline
Relationship between acute kidney injury and mineral bone disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 34056678Agar A, Gulabi D, Sahin A, Gunes O, Hancerli CO, Kilic B, Erturk C. Acute kidney injury after hip fracture surgery in patients over 80 years of age. Arch Orthop Trauma Surg. 2022 Sep;142(9):2245-2252. doi: 10.1007/s00402-021-03969-y. Epub 2021 May 31.
- Background: PubMed 23652554Koizumi M, Komaba H, Fukagawa M. Parathyroid function in chronic kidney disease: role of FGF23-Klotho axis. Contrib Nephrol. 2013;180:110-23. doi: 10.1159/000346791. Epub 2013 May 3.
- Results publication: PubMed 23381010Wesseling-Perry K, Salusky IB. Phosphate binders, vitamin D and calcimimetics in the management of chronic kidney disease-mineral bone disorders (CKD-MBD) in children. Pediatr Nephrol. 2013 Apr;28(4):617-25. doi: 10.1007/s00467-012-2381-8. Epub 2013 Feb 5.
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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 Acute Kidney Injury, 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 1 inclusion and 6 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 21 Sep 2022. 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 Asmaa Mohmed, طبيب مقيم (01113808804, Asmaaahmed17994@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between AKI and mineral bone disease (time frame: Baseline). 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 NCT05548725, 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 21 Sep 2022.