NCT05297214

Brief 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 . 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

March 13, 2022

Last Update Submit

March 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine level

    follow up AKI patients with serum creatinine level

    one year

Interventions

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

Also known as: 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

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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 .

You may qualify if:

  • All children with acute kidney injury with an age range from 1 month to 16 years old

You may not qualify if:

  • patients with chronic kidney disease (CKD)
  • Patients with irregular follow up
  • Patients with incomplete data
  • Patients whose medical guardians refuse participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag General Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27767356BACKGROUND
  • Akcay 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.

    PMID: 21694939BACKGROUND
  • Lameire 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.

    PMID: 14639067BACKGROUND
  • Kaddourah 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.

    PMID: 27959707BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Blood Cell CountKidney Function TestsBlood Gas AnalysisUrinalysis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaDiagnostic Techniques, UrologicalBlood Chemical AnalysisClinical Chemistry TestsRespiratory Function TestsDiagnostic Techniques, Respiratory System

Central Study Contacts

alzahraa A Ahmed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at pediateric department sohag General hospital

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 28, 2022

Study Start

January 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations