Acute Kidney InjuryNCT04768751
Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction
An observational study of Acute Kidney Injury and Ventricular Dysfunction, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury, Ventricular Dysfunction, Myocardium; Injury
- What is being tested?
- kidney assessment
- How many people
- 520 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2019to 30 Aug 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with normal kidney functions and free normal heart functions
Who may be able to join
- Patients with normal kidney functions and free normal heart functions, were enrolled to this study
Who cannot join
- patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Systolic Dysfunction After Non-Cardiac Surgery in Critical Patients
Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured .
Acute kidney injury is associated with significantly increased resource utilization and health care costs.
Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing non cardiac surgery is between 3% and 6%.
- Being tested
- kidney assessment
- Medical subject headings
- Acute Kidney Injury, Ventricular Dysfunction, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney assessmentDiagnostic test
Urea, BUN, and Creatinine BLOOD LEVELS
What is being measured
The primary outcome is the main question the study is designed to answer.
development myocardial injury
New echocardiographic findings suggestive of ischemia (new regional wall motion abnormalities) or cardiac troponin T >.0.32 ng/ml
Measured: through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start5 Mar 2019
- Primary completion20 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ali M. Elzohry, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768751
- Sponsor's protocol ID
- Acute Kidney injury
- Status last verified
- Feb 2021
- First submitted
- 20 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Systolic Dysfunction After Non-Cardiac Surgery in Critical Patients
- ClinicalTrials.gov ID
- NCT04768751
- Acronym / sponsor ID
- Acute Kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 24 Feb 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.
Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured .
Acute kidney injury is associated with significantly increased resource utilization and health care costs.
Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing non cardiac surgery is between 3% and 6%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with normal kidney functions and free normal heart functions
Key inclusion criteria (1 listed)
- Patients with normal kidney functions and free normal heart functions, were enrolled to this study
Key exclusion criteria (1 listed)
- patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.
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 |
|---|---|---|
| kidney assessmentUrea, BUN, and Creatinine BLOOD LEVELS | Diagnostic test | – |
Primary outcome
development myocardial injury
Time frame: through study completion, an average of 15 days
New echocardiographic findings suggestive of ischemia (new regional wall motion abnormalities) or cardiac troponin T >.0.32 ng/ml
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 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Kidney Injury and Ventricular Dysfunction, run by South Egypt Cancer Institute 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 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: finished, as of the sponsor's last update on 24 Feb 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 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?
development myocardial injury (time frame: through study completion, an average of 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.