Acute Kidney InjuryNCT06117826
Incidince of Acute Kidney Injury in Children With Community Acquired Pneumonia at Assiut University Children Hospital
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
Descriptive prospective observational study of Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 31 Mar 2025
- 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 30 days to 18 years
- All sexes
- Child, Adult
Study population: Children hospitalized with community-acquired pneumonia
Who may be able to join
- Patients age <18 years who are diagnosed with x-ray confirmed communityacquired pneumonia(CAP)
Who cannot join
- We excluded patients with preexistent comorbidities potentially affecting the Severity of pneumonia
Trial locations and contacts
No sites are listed yet.
About this study
Descriptive prospective observational study of Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital
Read the detailed description
Community acquired pneumonia (CAP) is a prevalent cause of infectious mortality worldwide [1, 2]. The number of patients hospitalized with CAP in the United States has been estimated to have reached one million in 2020, with similarly significant increases globally [3]. In Egypt, it was estimated that 10% of children deaths below the age of 5 years is likely caused by pneumonia and other acute respiratory infections [4] Acute kidney injury (AKI) is an abrupt decrease in glomerular filtration rate that can lead to health consequences for children in both the short and long term [5]. In fact, AKI may increase hospitalization length and morbidity and mortality rates for patients in the short term. Meanwhile, it exposes them to an increased risk of chronic kidney disease (CKD) over time. Even mild AKI doubles the risk of CKD during follow-up [6] . AKI is a common condition among hospitalized children. Reports indicate that AKI can exacerbate several typical pediatric disorders, such as acute gastroenteritis with an AKI prevalence of around 25% [7], type 1 diabetes mellitus onset with a prevalence rate of approximately 45% [8], and acute appendicitis at roughly 7% incidence levels[9] . Acute kidney injury (AKI) frequently complicates CAP; its incidence ranges from18-34 %in CAP patients[10-12]. Chawla et al., previously reported that coexisting pneumonia and AKI led to worse outcomes than either pneumonia or AKI alone[13]. Even among non-severe cases diagnosed only as pneumonia, however,Aki was associated with long-term mortality[11]. Despite this evidence, the impactof Aki on inhospital outcomes remains unclear for Egyptian populations . Adults suffering from CAP present considerable risks when it comes to developing both acute kidney injury(AKI)[14-15]and later chronic kidney disease(CKD)[16]; we hypothesize that there might be under-recognition regarding the prevalence of AKIs among children hospitalized due to CAP-especially milder forms. Indeed even milder forms double CKD risks during follow-ups.[17]Thus,it becomes crucially important to detect any episodes of Aki in order plan appropriate patient follow-ups.
- 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.
Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital
Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (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 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Fathy Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117826
- Sponsor's protocol ID
- Incidence of kidney injury
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.
PubMed 28919116Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, Stockmann C, Anderson EJ, Grijalva CG, Self WH, Zhu Y, Patel A, Hymas W, Chappell JD, Kaufman RA, Kan JH, Dansie D, Lenny N, Hillyard DR, Haynes LM, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Finelli L; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 2015 Feb 26;372(9):835-45. doi: 10.1056/NEJMoa1405870.
PubMed 25714161Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
PubMed 22113526Chawla LS, Amdur RL, Faselis C, Li P, Kimmel PL, Palant CE. Impact of Acute Kidney Injury in Patients Hospitalized With Pneumonia. Crit Care Med. 2017 Apr;45(4):600-606. doi: 10.1097/CCM.0000000000002245.
PubMed 28291091
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidince of Acute Kidney Injury in Children With Community Acquired Pneumonia at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06117826
- Acronym / sponsor ID
- Incidence of kidney injury
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Nov 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.
Descriptive prospective observational study of Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital
Detailed description
Community acquired pneumonia (CAP) is a prevalent cause of infectious mortality worldwide [1, 2]. The number of patients hospitalized with CAP in the United States has been estimated to have reached one million in 2020, with similarly significant increases globally [3]. In Egypt, it was estimated that 10% of children deaths below the age of 5 years is likely caused by pneumonia and other acute respiratory infections [4] Acute kidney injury (AKI) is an abrupt decrease in glomerular filtration rate that can lead to health consequences for children in both the short and long term [5]. In fact, AKI may increase hospitalization length and morbidity and mortality rates for patients in the short term. Meanwhile, it exposes them to an increased risk of chronic kidney disease (CKD) over time. Even mild AKI doubles the risk of CKD during follow-up [6] . AKI is a common condition among hospitalized children. Reports indicate that AKI can exacerbate several typical pediatric disorders, such as acute gastroenteritis with an AKI prevalence of around 25% [7], type 1 diabetes mellitus onset with a prevalence rate of approximately 45% [8], and acute appendicitis at roughly 7% incidence levels[9] . Acute kidney injury (AKI) frequently complicates CAP; its incidence ranges from18-34 %in CAP patients[10-12]. Chawla et al., previously reported that coexisting pneumonia and AKI led to worse outcomes than either pneumonia or AKI alone[13]. Even among non-severe cases diagnosed only as pneumonia, however,Aki was associated with long-term mortality[11]. Despite this evidence, the impactof Aki on inhospital outcomes remains unclear for Egyptian populations . Adults suffering from CAP present considerable risks when it comes to developing both acute kidney injury(AKI)[14-15]and later chronic kidney disease(CKD)[16]; we hypothesize that there might be under-recognition regarding the prevalence of AKIs among children hospitalized due to CAP-especially milder forms. Indeed even milder forms double CKD risks during follow-ups.[17]Thus,it becomes crucially important to detect any episodes of Aki in order plan appropriate patient follow-ups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children hospitalized with community-acquired pneumonia
Key inclusion criteria (1 listed)
- Patients age <18 years who are diagnosed with x-ray confirmed communityacquired pneumonia(CAP)
Key exclusion criteria (1 listed)
- We excluded patients with preexistent comorbidities potentially affecting the Severity of pneumonia
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
Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital
Time frame: Baseline
Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 28919116GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.
- Background: PubMed 25714161Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, Stockmann C, Anderson EJ, Grijalva CG, Self WH, Zhu Y, Patel A, Hymas W, Chappell JD, Kaufman RA, Kan JH, Dansie D, Lenny N, Hillyard DR, Haynes LM, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Finelli L; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 2015 Feb 26;372(9):835-45. doi: 10.1056/NEJMoa1405870.
- Background: PubMed 22113526Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
- Background: PubMed 28291091Chawla LS, Amdur RL, Faselis C, Li P, Kimmel PL, Palant CE. Impact of Acute Kidney Injury in Patients Hospitalized With Pneumonia. Crit Care Med. 2017 Apr;45(4):600-606. doi: 10.1097/CCM.0000000000002245.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Mahmoud Fathy (+01157121057 ext. +201099369325, mmfathy56@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidince of acute kidney injury in children with community acquired pneumonia at assiut university children hospital (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 NCT06117826, 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 5 Mar 2024.