AKI - Acute Kidney InjuryNCT06051708
Risk Factors And Outcomes Of Hospital Acquired AKI
An observational study of AKI - Acute Kidney Injury, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in Alexandria Main University hospital and their outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury
- What is being tested?
- standard AKI care bundle
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 15 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This research is a prospective cohort study that will include hospitalized patients in Alexandria Main University Hospital (in non-intensive care unit sittings) admitted over a period of sixteen weeks. Patients will be divided into two groups: Group (A) : patients who are hospitalized and develop acute kidney injury after 48 hours from admission. Group (B) : patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge. All participants will be followed till discharge and after 3 months to assess outcomes.
Who may be able to join
- Fulfilment of definition of acute kidney injury according to KDIGO reference.
- Age more than 18 years.
Who cannot join
- Mentally or physically unfit patients.
- Patients who developed acute kidney injury within 48 hours of admission to hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors And Outcomes Of Hospital Acquired Acute Kidney Injury: A Tertiary Health Care Center Experience
The aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in Alexandria Main University hospital and their outcomes.
Read the detailed description
Hospital-acquired AKI (HAAKI) is defined as acute renal insult occurring 48 hours or more after admission to a health care facility and It is estimated to occur in 13-18% of hospitalized patients. The early diagnosis of HAAKI reflects on improvement in morbidity and mortality rates especially in developing countries which goes parallel with the goal The International Society of Nephrology (ISN) to eliminate preventable or treatable deaths from AKI by 2025, the "0 by 25" initiative.
Data concerning the spectrum of acute kidney injury (AKI) in Egypt are generally scarce.
- Conditions
- AKI - Acute Kidney Injury
- Being tested
- standard AKI care bundle, standard care for hospitalized patients
- Keywords
- AKI, Hospital Acquired, risk factors, outcomes
- 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.
standard AKI care bundleOther
AKI care bundle include use of iv fluids, diuretics, antihyperkalemic drugs, sodium bicarbonate, antibiotics in septic patients.
standard care for hospitalized patientsOther
this includes iv fluids, diuretics, antibiotics in septic patients, other measures according to original disease
| Study group | Role | What they receive |
|---|---|---|
| AKI group | patients who are hospitalized and develop acute kidney injury after 48 hours from admission Receives: Other: standard AKI care bundle | |
| no AKI group | patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge Receives: Other: standard care for hospitalized patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of kidney functions
(improvement of eGFR, serum creatinine to normal or previous baseline).
Measured: 12 weeks
Secondary outcomes (3)
progression to chronic kidney disease.
deterioration of kidney functions ( creatinine, eGFR)
Measured: 12 weeks
mortality
death
Measured: 12 weeks
Need for renal replacement therapy
different modalities of RRT
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Hala S ElWakil, MD, Principal investigator, professoryasmine s naga, MD, Study chair, ASS. profMohamed mamdouh Elsayed, MD, Study chair, Lecturersara R Nagib, MBBCh, Study chair, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051708
- Sponsor's protocol ID
- Hospiat Acq. AKI
- Status last verified
- Jun 2024
- First submitted
- 17 Sep 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh TB, Rathore SS, Choudhury TA, Shukla VK, Singh DK, Prakash J. Hospital-acquired acute kidney injury in medical, surgical, and intensive care unit: A comparative study. Indian J Nephrol. 2013 Jan;23(1):24-9. doi: 10.4103/0971-4065.107192.
PubMed 23580801Sawhney S, Mitchell M, Marks A, Fluck N, Black C. Long-term prognosis after acute kidney injury (AKI): what is the role of baseline kidney function and recovery? A systematic review. BMJ Open. 2015 Jan 6;5(1):e006497. doi: 10.1136/bmjopen-2014-006497.
PubMed 25564144Hsu CN, Lee CT, Su CH, Wang YL, Chen HL, Chuang JH, Tain YL. Incidence, Outcomes, and Risk Factors of Community-Acquired and Hospital-Acquired Acute Kidney Injury: A Retrospective Cohort Study. Medicine (Baltimore). 2016 May;95(19):e3674. doi: 10.1097/MD.0000000000003674.
PubMed 27175701Ponce D, Balbi A. Acute kidney injury: risk factors and management challenges in developing countries. Int J Nephrol Renovasc Dis. 2016 Aug 22;9:193-200. doi: 10.2147/IJNRD.S104209. eCollection 2016.
PubMed 27578995
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors And Outcomes Of Hospital Acquired Acute Kidney Injury: A Tertiary Health Care Center Experience
- ClinicalTrials.gov ID
- NCT06051708
- Acronym / sponsor ID
- Hospiat Acq. AKI
- Conditions
- AKI - Acute Kidney Injury
- Keywords
- AKI, Hospital Acquired, risk factors, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 25 Sep 2023 (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 aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in Alexandria Main University hospital and their outcomes.
Detailed description
Hospital-acquired AKI (HAAKI) is defined as acute renal insult occurring 48 hours or more after admission to a health care facility and It is estimated to occur in 13-18% of hospitalized patients. The early diagnosis of HAAKI reflects on improvement in morbidity and mortality rates especially in developing countries which goes parallel with the goal The International Society of Nephrology (ISN) to eliminate preventable or treatable deaths from AKI by 2025, the "0 by 25" initiative.
Data concerning the spectrum of acute kidney injury (AKI) in Egypt are generally scarce.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI group | – | Other: standard AKI care bundlepatients who are hospitalized and develop acute kidney injury after 48 hours from admission |
| no AKI group | – | Other: standard care for hospitalized patientspatients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research is a prospective cohort study that will include hospitalized patients in Alexandria Main University Hospital (in non-intensive care unit sittings) admitted over a period of sixteen weeks. Patients will be divided into two groups: Group (A) : patients who are hospitalized and develop acute kidney injury after 48 hours from admission. Group (B) : patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge. All participants will be followed till discharge and after 3 months to assess outcomes.
Key inclusion criteria (2 listed)
- Fulfilment of definition of acute kidney injury according to KDIGO reference.
- Age more than 18 years.
Key exclusion criteria (2 listed)
- Mentally or physically unfit patients.
- Patients who developed acute kidney injury within 48 hours of admission to hospital.
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 |
|---|---|---|
| standard AKI care bundleAKI care bundle include use of iv fluids, diuretics, antihyperkalemic drugs, sodium bicarbonate, antibiotics in septic patients. | Other | AKI group |
| standard care for hospitalized patientsthis includes iv fluids, diuretics, antibiotics in septic patients, other measures according to original disease | Other | no AKI group |
Primary outcome
Recovery of kidney functions
Time frame: 12 weeks
(improvement of eGFR, serum creatinine to normal or previous baseline).
3 secondary outcomes
progression to chronic kidney disease.
Time frame: 12 weeks
mortality
Time frame: 12 weeks
Need for renal replacement therapy
Time frame: 12 weeks
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 18 Jun 2024.
- Background: PubMed 23580801Singh TB, Rathore SS, Choudhury TA, Shukla VK, Singh DK, Prakash J. Hospital-acquired acute kidney injury in medical, surgical, and intensive care unit: A comparative study. Indian J Nephrol. 2013 Jan;23(1):24-9. doi: 10.4103/0971-4065.107192.
- Background: PubMed 25564144Sawhney S, Mitchell M, Marks A, Fluck N, Black C. Long-term prognosis after acute kidney injury (AKI): what is the role of baseline kidney function and recovery? A systematic review. BMJ Open. 2015 Jan 6;5(1):e006497. doi: 10.1136/bmjopen-2014-006497.
- Background: PubMed 27175701Hsu CN, Lee CT, Su CH, Wang YL, Chen HL, Chuang JH, Tain YL. Incidence, Outcomes, and Risk Factors of Community-Acquired and Hospital-Acquired Acute Kidney Injury: A Retrospective Cohort Study. Medicine (Baltimore). 2016 May;95(19):e3674. doi: 10.1097/MD.0000000000003674.
- Background: PubMed 27578995Ponce D, Balbi A. Acute kidney injury: risk factors and management challenges in developing countries. Int J Nephrol Renovasc Dis. 2016 Aug 22;9:193-200. doi: 10.2147/IJNRD.S104209. eCollection 2016.
- 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.
Hala S ElWakil, MD principal investigator
professor
yasmine s naga, MD study chair
ASS. prof
Mohamed mamdouh Elsayed, MD study chair
Lecturer
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 AKI - Acute Kidney Injury, run by Alexandria 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 2 inclusion and 2 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 18 Jun 2024. 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?
Recovery of kidney functions (time frame: 12 weeks). 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 NCT06051708, which also lists 4 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 18 Jun 2024.