Acute Kidney InjuryNCT05297214
A Study of Acute Kidney Injury in Children at Sohag University Hospital
An observational study of Acute Kidney Injury, run by Sohag University at 1 site in Egypt.
Trial summary
Acute kidney injury (AKI) has been traditionally defined as an abrupt loss of kidney function leading to a rapid decline in the glomerular filtration rate (GFR), accumulation of waste products such as blood urea nitrogen (BUN) and creatinine, and dysregulation of extracellular volume and electrolyte homeostasis . Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- serum creatinine and Other investigations will be done according to the case
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 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 1 month to 16 years
- All sexes
- Child
Study population: Acute kidney injury (AKI) will be defined by the presence of an Increase in serum creatinine by 0.3 mg/dL or more within 48 hours, or increase in serum creatinine to 1.5 times or more baseline within the prior seven days, or urine output less than 0.5 mL/kg/h for at least 6 hours . AKI will be classified according to serum creatinine level (SCr) and urine output as in table .
Who may be able to join
- All children with acute kidney injury with an age range from 1 month to 16 years old
Who cannot join
- patients with chronic kidney disease (CKD)
- Patients with irregular follow up
- Patients with incomplete data
- Patients whose medical guardians refuse participation in the study
Trial locations and contacts
1 site in 1 country.
alzahraa A Ahmed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag General Hospital
Sohag
Osama R ElSherif, professor, portal@med.sohag.edu.eg
About this study
Acute kidney injury (AKI) has been traditionally defined as an abrupt loss of kidney function leading to a rapid decline in the glomerular filtration rate (GFR), accumulation of waste products such as blood urea nitrogen (BUN) and creatinine, and dysregulation of extracellular volume and electrolyte homeostasis . Acute kidney injury (AKI) is a very common condition, especially among hospitalized patients.
this work aims to study the demographics, etiology, clinical characteristics, and outcome of acute kidney injury in children in Sohag University Hospital - Pediatrics Department.
- Conditions
- Acute Kidney Injury
- Being tested
- serum creatinine and Other investigations will be done according to the case
- 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.
serum creatinine and Other investigations will be done according to the caseDiagnostic test
Also called complete blood count, kidney function tests, blood gases, serum electrolytes, and urine analysis,abdominal ultrasound, others according to case as C3,c4,ANA,ANCA,AntidsDNA,Protein creatinin ratio
following up AKI patients with serum creatinine,Urine out put, CBC,Serum electrolytes,renal functin test,Liver function test,urine analysisand specific investigations according to case
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine level
follow up AKI patients with serum creatinine level
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 posted28 Mar 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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 Sohag 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Abdelsabour Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297214
- Sponsor's protocol ID
- soh-Med-22-03-11
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tresa V, Yaseen A, Lanewala AA, Hashmi S, Khatri S, Ali I, Mubarak M. Etiology, clinical profile and short-term outcome of acute kidney injury in children at a tertiary care pediatric nephrology center in Pakistan. Ren Fail. 2017 Nov;39(1):26-31. doi: 10.1080/0886022X.2016.1244074. Epub 2016 Oct 21.
PubMed 27767356Akcay A, Turkmen K, Lee D, Edelstein CL. Update on the diagnosis and management of acute kidney injury. Int J Nephrol Renovasc Dis. 2010;3:129-40. doi: 10.2147/IJNRD.S8641. Epub 2010 Sep 29.
PubMed 21694939Lameire NH, De Vriese AS, Vanholder R. Prevention and nondialytic treatment of acute renal failure. Curr Opin Crit Care. 2003 Dec;9(6):481-90. doi: 10.1097/00075198-200312000-00004.
PubMed 14639067Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL; AWARE Investigators. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med. 2017 Jan 5;376(1):11-20. doi: 10.1056/NEJMoa1611391. Epub 2016 Nov 18.
PubMed 27959707
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Acute Kidney Injury in Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05297214
- Acronym / sponsor ID
- soh-Med-22-03-11
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 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.
Acute kidney injury (AKI) has been traditionally defined as an abrupt loss of kidney function leading to a rapid decline in the glomerular filtration rate (GFR), accumulation of waste products such as blood urea nitrogen (BUN) and creatinine, and dysregulation of extracellular volume and electrolyte homeostasis . Acute kidney injury (AKI) is a very common condition, especially among hospitalized patients.
this work aims to study the demographics, etiology, clinical characteristics, and outcome of acute kidney injury in children in Sohag University Hospital - Pediatrics Department.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Acute kidney injury (AKI) will be defined by the presence of an Increase in serum creatinine by 0.3 mg/dL or more within 48 hours, or increase in serum creatinine to 1.5 times or more baseline within the prior seven days, or urine output less than 0.5 mL/kg/h for at least 6 hours . AKI will be classified according to serum creatinine level (SCr) and urine output as in table .
Key inclusion criteria (1 listed)
- All children with acute kidney injury with an age range from 1 month to 16 years old
Key exclusion criteria (4 listed)
- patients with chronic kidney disease (CKD)
- Patients with irregular follow up
- Patients with incomplete data
- Patients whose medical guardians refuse participation 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 |
|---|---|---|
| serum creatinine and Other investigations will be done according to the caseAlso: complete blood count, kidney function tests, blood gases, serum electrolytes, and urine analysis,abdominal ultrasound, others according to case as C3,c4,ANA,ANCA,AntidsDNA,Protein creatinin ratiofollowing up AKI patients with serum creatinine,Urine out put, CBC,Serum electrolytes,renal functin test,Liver function test,urine analysisand specific investigations according to case | Diagnostic test | – |
Primary outcome
Serum creatinine level
Time frame: one year
follow up AKI patients with serum creatinine level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Background: PubMed 27767356Tresa V, Yaseen A, Lanewala AA, Hashmi S, Khatri S, Ali I, Mubarak M. Etiology, clinical profile and short-term outcome of acute kidney injury in children at a tertiary care pediatric nephrology center in Pakistan. Ren Fail. 2017 Nov;39(1):26-31. doi: 10.1080/0886022X.2016.1244074. Epub 2016 Oct 21.
- Background: PubMed 21694939Akcay A, Turkmen K, Lee D, Edelstein CL. Update on the diagnosis and management of acute kidney injury. Int J Nephrol Renovasc Dis. 2010;3:129-40. doi: 10.2147/IJNRD.S8641. Epub 2010 Sep 29.
- Background: PubMed 14639067Lameire NH, De Vriese AS, Vanholder R. Prevention and nondialytic treatment of acute renal failure. Curr Opin Crit Care. 2003 Dec;9(6):481-90. doi: 10.1097/00075198-200312000-00004.
- Background: PubMed 27959707Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL; AWARE Investigators. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med. 2017 Jan 5;376(1):11-20. doi: 10.1056/NEJMoa1611391. Epub 2016 Nov 18.
- 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.
alzahraa A Ahmed, professor contact
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 Sohag 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 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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 omnia A Hassan, resident (01062038698, omnia_abdelsabour_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine level (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 NCT05297214, 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 28 Mar 2022.