Acute Kidney InjuryNCT05268211
Diagnostic Performance of Two Tools
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
Developing new tools for early detection of AKI in open-heart surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- urinary oxygen partial pressure
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Dec 2024
- How long will I take part?
- 3 Days
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrollment of patients will be done through Assiut university Heart hospital after approval from the local ethics committee of the Faculty of Medicine, Assiut University
Who may be able to join
- Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes
Who cannot join
- Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.
About this study
Official title: Diagnostic Performance of Two Tools for Early Prediction of Acute Kidney Injury After Open-heart Surgery
Developing new tools for early detection of AKI in open-heart surgeries.
- Conditions
- Acute Kidney Injury
- Being tested
- urinary oxygen partial pressure
- 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.
urinary oxygen partial pressureDiagnostic test
measuring urinary oxygen partial pressure and measuring US Doppler renal resistive index
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury
Incidence of AKI according to AKIN criteria
Measured: up to 48 hours
Urinary oxygen partial pressure
Urinary oxygen partial pressure measured in mmHg at induction, before rewarming and in the ICU
Measured: up to 48 hours
Renal resistive index
Renal resistive index measured at induction and in the ICU
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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.
- 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
- 130 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Medhat Mahfouz Eshak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268211
- Sponsor's protocol ID
- IRB 5891
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Two Tools for Early Prediction of Acute Kidney Injury After Open-heart Surgery
- ClinicalTrials.gov ID
- NCT05268211
- Acronym / sponsor ID
- IRB 5891
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 Mar 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.
Developing new tools for early detection of AKI in open-heart surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment of patients will be done through Assiut university Heart hospital after approval from the local ethics committee of the Faculty of Medicine, Assiut University
Key inclusion criteria (1 listed)
- Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes
Key exclusion criteria (1 listed)
- Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.
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 |
|---|---|---|
| urinary oxygen partial pressuremeasuring urinary oxygen partial pressure and measuring US Doppler renal resistive index | Diagnostic test | – |
Primary outcome
Incidence of acute kidney injury
Time frame: up to 48 hours
Incidence of AKI according to AKIN criteria
Urinary oxygen partial pressure
Time frame: up to 48 hours
Urinary oxygen partial pressure measured in mmHg at induction, before rewarming and in the ICU
Renal resistive index
Time frame: up to 48 hours
Renal resistive index measured at induction and in the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 7 Mar 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?
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?
Incidence of acute kidney injury (time frame: up to 48 hours). 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?
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 7 Mar 2022.