Acute Kidney InjuryNCT04101110
Transition of Acute Kidney Injury to Chronic Kidney Disease
An observational study of Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Acute kidney injury is a complex clinical syndrome,associated with high short and long- term morbidity and mortality in critical ill patients.Acute kidney injury outcomes may vary from a complete resolution to a partial or incomplete recovery of renal function leading to increased mortality,prolonged hospitalization… 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?
- Renal biopsy
- How many people
- 252 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Dec 2022
- 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
- Adult, Older adult
Study population: All patients attending Assiut university hospitals critical care unit and developing acute kidney injury during their stay.
Who may be able to join
- patients ≥18 years;
- patients suffering an acute kidney injury (defined by Acute kidney injury network (AKIN) score ≥1)during ICU stay.
Who cannot join
- patients <18 years;
- pregnant woman;
- End stage renal disease (ESRD)prior to ICU admission;
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology, Risk Factors and Outcomes of Transition of Acute Kidney Injury to Chronic Kidney Disease in Critically Ill Patients
Acute kidney injury is a complex clinical syndrome,associated with high short and long- term morbidity and mortality in critical ill patients.Acute kidney injury outcomes may vary from a complete resolution to a partial or incomplete recovery of renal function leading to increased mortality,prolonged hospitalization and risk of chronic comorbidities .
The precise mechanism of acute kidney injury to chronic kidney disease transition is complex and not completely understood,especially in humans .Acute kidney injury outcomes depend upon the balance of adaptive and maladaptive repair.
Read the detailed description
Acute kidney injury is a life threatening and disabling complication of critical illness encountered in 25 -50%h of intensive care unit admission.Acute kidney injury is a complex clinical syndrome,associated with high short and long- term morbidity and mortality in critical ill patients.
Acute kidney injury outcomes may vary from a complete resolution to a partial or incomplete recovery of renal function leading to increased mortality,prolonged hospitalization and risk of chronic comorbidities like cardiovascular disease,chronic kidney disease and subsequent progression to end stage renal disease.Several studies have suggested a causal link between acute kidney injury and the consequent development of chronic kidney disease.the severity,frequency and duration of acute kidney injury are key factors in this process.
The precise mechanism of transition of acute kidney injury to chronic kidney disease is complex and not completely understood,especially in humans and several pathways have been proposed. Different animal studies have used ischemia-reperfusion and nephrotoxic injuries to investigate the pathophysiologic event involved in acute kidney injury to chronic kidney disease transition ,mainly focusing in the development of specific histological changes .Acute kidney injury outcomes depend, at the tissue level,upon the balance of adaptive and maladaptive repair. An adaptive response to injury usually leads to renal recovery with a complete resolution of pathological changes during acute kidney injury episode(resolution of inflammatory cell infiltration, regeneration of tubular cells,decrease in biomarkers of injury )without long term consequences .However,severe and repeated injury can result in a maladaptive repair,characterized by a permanent reduction in kidney function associated with significant structural changes (persistent expression of pro-fibrotic factors and development of interstitial fibrosis, delayed resolution of inflammation,permanent cell cycle arrest of tubular cells, microvascular rarefaction,renin angiotensin system activation).
The incidence rate of renal progression following acute kidney injury has been estimated to be 4.9 events /100 patient-year and is particularly increase in elderly.
- Conditions
- Acute Kidney Injury
- Being tested
- Renal biopsy
- 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.
Renal biopsyOther
Kidney biopsy will be done to understand the nature and degree of structural kidney damage
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic kidney disease
Incidence of chronic kidney disease defined by a decreased glomerular filtration rate under 60 mL/minute/1.73m2
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Apr 2021
- Primary completion1 Sep 2021
- Study completion1 Dec 2022
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 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa A Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101110
- Sponsor's protocol ID
- EROT
- Status last verified
- Jul 2020
- First submitted
- 19 Sep 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sileanu FE, Murugan R, Lucko N, Clermont G, Kane-Gill SL, Handler SM, Kellum JA. AKI in low-risk versus high-risk patients in intensive care. Clin J Am Soc Nephrol. 2015 Feb 6;10(2):187-96. doi: 10.2215/CJN.03200314. Epub 2014 Nov 25.
PubMed 25424992Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
PubMed 21975865Goldstein SL, Chawla L, Ronco C, Kellum JA. Renal recovery. Crit Care. 2014 Jan 6;18(1):301. doi: 10.1186/cc13180.
PubMed 24393370
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Risk Factors and Outcomes of Transition of Acute Kidney Injury to Chronic Kidney Disease in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04101110
- Acronym / sponsor ID
- EROT
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 24 Sep 2019 (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 is a complex clinical syndrome,associated with high short and long- term morbidity and mortality in critical ill patients.Acute kidney injury outcomes may vary from a complete resolution to a partial or incomplete recovery of renal function leading to increased mortality,prolonged hospitalization and risk of chronic comorbidities .
The precise mechanism of acute kidney injury to chronic kidney disease transition is complex and not completely understood,especially in humans .Acute kidney injury outcomes depend upon the balance of adaptive and maladaptive repair.
Detailed description
Acute kidney injury is a life threatening and disabling complication of critical illness encountered in 25 -50%h of intensive care unit admission.Acute kidney injury is a complex clinical syndrome,associated with high short and long- term morbidity and mortality in critical ill patients.
Acute kidney injury outcomes may vary from a complete resolution to a partial or incomplete recovery of renal function leading to increased mortality,prolonged hospitalization and risk of chronic comorbidities like cardiovascular disease,chronic kidney disease and subsequent progression to end stage renal disease.Several studies have suggested a causal link between acute kidney injury and the consequent development of chronic kidney disease.the severity,frequency and duration of acute kidney injury are key factors in this process.
The precise mechanism of transition of acute kidney injury to chronic kidney disease is complex and not completely understood,especially in humans and several pathways have been proposed. Different animal studies have used ischemia-reperfusion and nephrotoxic injuries to investigate the pathophysiologic event involved in acute kidney injury to chronic kidney disease transition ,mainly focusing in the development of specific histological changes .Acute kidney injury outcomes depend, at the tissue level,upon the balance of adaptive and maladaptive repair. An adaptive response to injury usually leads to renal recovery with a complete resolution of pathological changes during acute kidney injury episode(resolution of inflammatory cell infiltration, regeneration of tubular cells,decrease in biomarkers of injury )without long term consequences .However,severe and repeated injury can result in a maladaptive repair,characterized by a permanent reduction in kidney function associated with significant structural changes (persistent expression of pro-fibrotic factors and development of interstitial fibrosis, delayed resolution of inflammation,permanent cell cycle arrest of tubular cells, microvascular rarefaction,renin angiotensin system activation).
The incidence rate of renal progression following acute kidney injury has been estimated to be 4.9 events /100 patient-year and is particularly increase in elderly.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients attending Assiut university hospitals critical care unit and developing acute kidney injury during their stay.
Key inclusion criteria (2 listed)
- patients ≥18 years;
- patients suffering an acute kidney injury (defined by Acute kidney injury network (AKIN) score ≥1)during ICU stay.
Key exclusion criteria (4 listed)
- patients <18 years;
- pregnant woman;
- End stage renal disease (ESRD)prior to ICU admission;
- Refusal to participate in 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 |
|---|---|---|
| Renal biopsyKidney biopsy will be done to understand the nature and degree of structural kidney damage | Other | – |
Primary outcome
Incidence of chronic kidney disease
Time frame: Baseline
Incidence of chronic kidney disease defined by a decreased glomerular filtration rate under 60 mL/minute/1.73m2
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 27 Jul 2023.
- Results publication: PubMed 25424992Sileanu FE, Murugan R, Lucko N, Clermont G, Kane-Gill SL, Handler SM, Kellum JA. AKI in low-risk versus high-risk patients in intensive care. Clin J Am Soc Nephrol. 2015 Feb 6;10(2):187-96. doi: 10.2215/CJN.03200314. Epub 2014 Nov 25.
- Results publication: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Results publication: PubMed 21975865Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
- Results publication: PubMed 24393370Goldstein SL, Chawla L, Ronco C, Kellum JA. Renal recovery. Crit Care. 2014 Jan 6;18(1):301. doi: 10.1186/cc13180.
- 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, 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 2 inclusion and 4 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 27 Jul 2023. 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?
Incidence of chronic kidney disease (time frame: Baseline). 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 NCT04101110, 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 27 Jul 2023.