Acute Kidney InjuryNCT04264507
Prevalence , Risk Factors and Outcomes of AKI in ICU Patients
An observational study of Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 254 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 31 Dec 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: cases of AKI admitted to ICU in internal medicine department or developed AKI during hospital stay.
Who may be able to join
- All patients >18 years admitted to medical ICU in Internal Medicine Department with critical medical conditions who develop AKI during hospital admission or presented with AKI
Who cannot join
- Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university Hospital
Asyut, Assuit, 71511Assuit
Manal Adel, Master, 01140122723, Manalahmed1993@gmail.com
About this study
Official title: Prevalence and Outcomes of Acute Kidney Injury Among Medical ICU Patients in Assiut University Hospitals
Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people die of AKI every year. Those who survive AKI have a higher risk for later development of CKD(3). Epidemiology of AKI is understudied in developing countries so further studies are needed to estimate the burden of AKI among ICU patients.
Few studies about the epidemiology of AKI in Egypt were done;
Read the detailed description
Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days. According to KDIGO (kidney disease improving global outcomes) criteria: AKI is defined as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or. Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or. Urine output less than 0.5 mL/kg/h for 6 hours(1). Kidney Injury (AKI) affects over 13 million people per year globally and results in 1.7 million deaths. Recent hospital studies in the developed world report AKI in 3.2-9.6% of admissions, with overall in-hospital mortality around 20%, and up to 50% in ICU patients.
Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people die of AKI every year. Those who survive AKI have a higher risk for later development of CKD(3). Epidemiology of AKI is understudied in developing countries so further studies are needed to estimate the burden of AKI among ICU patients.
Few studies about the epidemiology of AKI in Egypt were done; Samar Abd ElHafeez e,tal 2017 found in a multicenter study of over 500 consecutive patients admitted to ICUs in Alexandria Teaching Hospitals in Egypt, that about 40% of patients admitted to ICU had AKI at presentation, and a similar proportion of those who were AKI-free on admission developed AKI during their ICU stay (4) .
Up to our knowledge, there are no sufficient data about the epidemiology of AKI in upper Egypt
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of AKI patients admitted to medical ICU in assiut university hospitals
Number of patients addimmted or developed aki during stay in icu
Measured: One year
Secondary outcomes (1)
The proportion of risk factor of AKI
Most common risk factors for aki in ice patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manal adel ahmed, Assiut University
- Investigators
- Walaa Hosny, Doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264507
- Sponsor's protocol ID
- Epidemiology of aki in icu
- Status last verified
- Jul 2021
- First submitted
- 16 Jan 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Summary of Recommendation Statements. Kidney Int Suppl (2011). 2012 Mar;2(1):8-12. doi: 10.1038/kisup.2012.7. No abstract available.
PubMed 25018916
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Outcomes of Acute Kidney Injury Among Medical ICU Patients in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04264507
- Acronym / sponsor ID
- Epidemiology of aki in icu
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Feb 2020 (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.
Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people die of AKI every year. Those who survive AKI have a higher risk for later development of CKD(3). Epidemiology of AKI is understudied in developing countries so further studies are needed to estimate the burden of AKI among ICU patients.
Few studies about the epidemiology of AKI in Egypt were done;
Detailed description
Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days. According to KDIGO (kidney disease improving global outcomes) criteria: AKI is defined as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or. Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or. Urine output less than 0.5 mL/kg/h for 6 hours(1). Kidney Injury (AKI) affects over 13 million people per year globally and results in 1.7 million deaths. Recent hospital studies in the developed world report AKI in 3.2-9.6% of admissions, with overall in-hospital mortality around 20%, and up to 50% in ICU patients.
Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people die of AKI every year. Those who survive AKI have a higher risk for later development of CKD(3). Epidemiology of AKI is understudied in developing countries so further studies are needed to estimate the burden of AKI among ICU patients.
Few studies about the epidemiology of AKI in Egypt were done; Samar Abd ElHafeez e,tal 2017 found in a multicenter study of over 500 consecutive patients admitted to ICUs in Alexandria Teaching Hospitals in Egypt, that about 40% of patients admitted to ICU had AKI at presentation, and a similar proportion of those who were AKI-free on admission developed AKI during their ICU stay (4) .
Up to our knowledge, there are no sufficient data about the epidemiology of AKI in upper Egypt
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- cases of AKI admitted to ICU in internal medicine department or developed AKI during hospital stay.
Key inclusion criteria (1 listed)
- All patients >18 years admitted to medical ICU in Internal Medicine Department with critical medical conditions who develop AKI during hospital admission or presented with AKI
Key exclusion criteria (1 listed)
- Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of AKI patients admitted to medical ICU in assiut university hospitals
Time frame: One year
Number of patients addimmted or developed aki during stay in icu
1 secondary outcome
The proportion of risk factor of AKI
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Results publication: PubMed 25018916Summary of Recommendation Statements. Kidney Int Suppl (2011). 2012 Mar;2(1):8-12. doi: 10.1038/kisup.2012.7. No abstract available.
- Summary of Recommendation Statements. Kidney Int SupplLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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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.
Walaa Hosny, Doctor study director
Assiut University
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, run by Assiut University 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: status not confirmed, as of the sponsor's last update on 23 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact manal ahmed, master (01156949520, manalahmed1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of AKI patients admitted to medical ICU in assiut university hospitals (time frame: One year). 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 NCT04264507, 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 23 Jul 2021.