NCT06177886

Brief Summary

This study aims to investigate the true incidence and clinical presentation of post-traumatic AKI in hospitalized pediatric patients and identify the risk, and severity of AKI. The results would aid the emergency physicians in the early identification of those at risk of AKI to establish a resuscitation strategy that aims at preventing AKI

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

December 2, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 2, 2023

Last Update Submit

December 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of AKI in Pediatric Trauma Patients Admitted to ER

    Describing the true incidence of AKI in pediatric trauma patients who are admitted to ER. a) Identification of AKI according to the KDIGO guidelines as follows: I. Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or II. Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or III. Urine volume \<0.5 mL/kg/hour for six hours

    baseline

  • timing of AKI in pediatric trauma patients admitted to ER

    time period between admission and diagnosis of AKI

    baseline

Secondary Outcomes (2)

  • Risk Identification of AKI in pediatric trauma patients

    baseline

  • mortality outcomes of AKI in pediatric trauma patients

    Baseline

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

From September 2023 till September 2024, all patients admitted to the emergency department who meet the eligibility criteria will be recruited in this study after obtaining informed consent from their legal guardians.

You may qualify if:

  • The present study will be conducted on pediatric patients with multiple traumas of both genders aged 2yr to 18 yr who have no previous history of kidney disease or chronic illness.

You may not qualify if:

  • Patients who are less than 2 years old or more than 18 years old.
  • Direct trauma kidney or localized individual trauma
  • children with preexisting kidney disease
  • children with drug nephrotoxicity
  • children underwent renal transplant
  • children post-cardiac arrest
  • Patients leaving the hospital on the same day or transferred to a different hospital will be excluded from this study.
  • Patients refusing the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Harrois A, Soyer B, Gauss T, Hamada S, Raux M, Duranteau J; Traumabase(R) Group. Prevalence and risk factors for acute kidney injury among trauma patients: a multicenter cohort study. Crit Care. 2018 Dec 18;22(1):344. doi: 10.1186/s13054-018-2265-9.

    PMID: 30563549BACKGROUND
  • Harrois A, Libert N, Duranteau J. Acute kidney injury in trauma patients. Curr Opin Crit Care. 2017 Dec;23(6):447-456. doi: 10.1097/MCC.0000000000000463.

    PMID: 29035925BACKGROUND
  • Reilly JP, Anderson BJ, Mangalmurti NS, Nguyen TD, Holena DN, Wu Q, Nguyen ET, Reilly MP, Lanken PN, Christie JD, Meyer NJ, Shashaty MG. The ABO Histo-Blood Group and AKI in Critically Ill Patients with Trauma or Sepsis. Clin J Am Soc Nephrol. 2015 Nov 6;10(11):1911-20. doi: 10.2215/CJN.12201214. Epub 2015 Sep 4.

    PMID: 26342043BACKGROUND
  • Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.

    PMID: 18661407BACKGROUND
  • Eriksson M, Brattstrom O, Martensson J, Larsson E, Oldner A. Acute kidney injury following severe trauma: Risk factors and long-term outcome. J Trauma Acute Care Surg. 2015 Sep;79(3):407-12. doi: 10.1097/TA.0000000000000727.

    PMID: 26307873BACKGROUND
  • Fujinaga J, Kuriyama A, Shimada N. Incidence and risk factors of acute kidney injury in the Japanese trauma population: A prospective cohort study. Injury. 2017 Oct;48(10):2145-2149. doi: 10.1016/j.injury.2017.08.022. Epub 2017 Aug 15.

    PMID: 28842286BACKGROUND
  • Santos PR, Monteiro DL. Acute kidney injury in an intensive care unit of a general hospital with emergency room specializing in trauma: an observational prospective study. BMC Nephrol. 2015 Mar 19;16:30. doi: 10.1186/s12882-015-0026-4.

    PMID: 25885883BACKGROUND
  • Talving P, Karamanos E, Skiada D, Lam L, Teixeira PG, Inaba K, Johnson J, Demetriades D. Relationship of creatine kinase elevation and acute kidney injury in pediatric trauma patients. J Trauma Acute Care Surg. 2013 Mar;74(3):912-6. doi: 10.1097/TA.0b013e318278954e.

    PMID: 23425757BACKGROUND
  • National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

    PMID: 11904577BACKGROUND
  • National Clinical Guideline Centre (UK). Acute Kidney Injury: Prevention, Detection and Management Up to the Point of Renal Replacement Therapy [Internet]. London: Royal College of Physicians (UK); 2013 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK247665/

    PMID: 25340231BACKGROUND
  • Ricci Z, Romagnoli S. Prescription of dialysis in pediatric acute kidney injury. Minerva Pediatr. 2015 Apr;67(2):159-67. Epub 2015 Jan 23.

    PMID: 25615028BACKGROUND
  • Kwiatkowski DM, Goldstein SL, Cooper DS, Nelson DP, Morales DL, Krawczeski CD. Peritoneal Dialysis vs Furosemide for Prevention of Fluid Overload in Infants After Cardiac Surgery: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):357-364. doi: 10.1001/jamapediatrics.2016.4538.

    PMID: 28241247BACKGROUND
  • Kwiatkowski DM, Menon S, Krawczeski CD, Goldstein SL, Morales DL, Phillips A, Manning PB, Eghtesady P, Wang Y, Nelson DP, Cooper DS. Improved outcomes with peritoneal dialysis catheter placement after cardiopulmonary bypass in infants. J Thorac Cardiovasc Surg. 2015 Jan;149(1):230-6. doi: 10.1016/j.jtcvs.2013.11.040. Epub 2013 Dec 31.

    PMID: 24503323BACKGROUND
  • Bojan M, Gioanni S, Vouhe PR, Journois D, Pouard P. Early initiation of peritoneal dialysis in neonates and infants with acute kidney injury following cardiac surgery is associated with a significant decrease in mortality. Kidney Int. 2012 Aug;82(4):474-81. doi: 10.1038/ki.2012.172.

    PMID: 22622499BACKGROUND
  • Webb TN, Goldstein SL. Congenital heart surgery and acute kidney injury. Curr Opin Anaesthesiol. 2017 Feb;30(1):105-112. doi: 10.1097/ACO.0000000000000406.

    PMID: 27748669BACKGROUND
  • Kellum JA, Bellomo R, Ronco C. Classification of acute kidney injury using RIFLE: What's the purpose? Crit Care Med. 2007 Aug;35(8):1983-4. doi: 10.1097/01.CCM.0000277518.67114.F8. No abstract available.

    PMID: 17667247BACKGROUND
  • de Abreu KL, Silva Junior GB, Barreto AG, Melo FM, Oliveira BB, Mota RM, Rocha NA, Silva SL, Araujo SM, Daher EF. Acute kidney injury after trauma: Prevalence, clinical characteristics and RIFLE classification. Indian J Crit Care Med. 2010 Jul;14(3):121-8. doi: 10.4103/0972-5229.74170.

    PMID: 21253345BACKGROUND
  • Li J, Han B, Li H, Deng H, Mendez-Sanchez N, Guo X, Qi X. Association of coagulopathy with the risk of bleeding after invasive procedures in liver cirrhosis. Saudi J Gastroenterol. 2018 Jul-Aug;24(4):220-227. doi: 10.4103/sjg.SJG_486_17.

    PMID: 29956689BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at emergency medicine department

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 20, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

December 20, 2023

Record last verified: 2023-12