Acute Kidney Injury (AKI)NCT05068167
Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery
An observational study of Acute Kidney Injury (AKI), run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury (AKI)
- What is being tested?
- Kidney function test
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 30 Sep 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 who were candidates for major surgery in the Cancer Institute of South Egypt, Assiut University, Egypt. Patients excluded from this study were patients with chronic cardiac diseases (myocardial ischemia, heart failure, Active severe infection, pregnancy, chronic kidney disease, DM, and advanced malignancy on chemotherapy or radiotherapy.
Who may be able to join
- patients who were candidates for major non cardiac surgery
Who cannot join
- chronic cardiac diseases (myocardial ischemia, heart failure), Active severe infection, pregnancy, chronic kidney disease
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 After Non Cardiac Surgery in Critical Patients
The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also with complications on long term, such as development of chronic kidney disease. A better understanding of the mechanism of this hypthesis will lead to better management of this complication.
Read the detailed description
A randomized blinded prospective study included 206patients who the candidate for major surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt. From April 2018 till April 2019, a detailed history and careful examination, routine laboratory investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours postoperative at ICU.
- Conditions
- Acute Kidney Injury (AKI)
- Being tested
- Kidney function test
- 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.
Kidney function testDiagnostic test
Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine level
Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours
Measured: every 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Mar 2019
- Primary completion30 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (AKI)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 240 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
- NCT05068167
- Sponsor's protocol ID
- ACI after non cardiac surgery
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 5 Oct 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 5 Oct 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 After Non Cardiac Surgery in Critical Patients
- ClinicalTrials.gov ID
- NCT05068167
- Acronym / sponsor ID
- ACI after non cardiac surgery
- Conditions
- Acute Kidney Injury (AKI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Oct 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 incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also with complications on long term, such as development of chronic kidney disease. A better understanding of the mechanism of this hypthesis will lead to better management of this complication.
Detailed description
A randomized blinded prospective study included 206patients who the candidate for major surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt. From April 2018 till April 2019, a detailed history and careful examination, routine laboratory investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours postoperative at ICU.
Study design
- Observational model
- Other
- 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 who were candidates for major surgery in the Cancer Institute of South Egypt, Assiut University, Egypt. Patients excluded from this study were patients with chronic cardiac diseases (myocardial ischemia, heart failure, Active severe infection, pregnancy, chronic kidney disease, DM, and advanced malignancy on chemotherapy or radiotherapy.
Key inclusion criteria (1 listed)
- patients who were candidates for major non cardiac surgery
Key exclusion criteria (1 listed)
- chronic cardiac diseases (myocardial ischemia, heart failure), Active severe infection, pregnancy, chronic kidney disease
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 function testCreatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours | Diagnostic test | – |
Primary outcome
Creatinine level
Time frame: every 12 hours
Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours
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 5 Oct 2021.
- 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.
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 (AKI), 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 5 Oct 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?
Creatinine level (time frame: every 12 hours). 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 5 Oct 2021.