NCT04101110

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

September 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

September 19, 2019

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic kidney disease

    Incidence of chronic kidney disease defined by a decreased glomerular filtration rate under 60 mL/minute/1.73m2

    Baseline

Interventions

Kidney biopsy will be done to understand the nature and degree of structural kidney damage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attending Assiut university hospitals critical care unit and developing acute kidney injury during their stay.

You may qualify if:

  • patients ≥18 years;
  • patients suffering an acute kidney injury (defined by Acute kidney injury network (AKIN) score ≥1)during ICU stay.

You may not qualify if:

  • patients \<18 years;
  • pregnant woman;
  • End stage renal disease (ESRD)prior to ICU admission;
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

Related Publications (4)

  • 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.

  • Hoste 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.

  • Singbartl 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.

  • Goldstein SL, Chawla L, Ronco C, Kellum JA. Renal recovery. Crit Care. 2014 Jan 6;18(1):301. doi: 10.1186/cc13180.

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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinsipal Investigator

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 24, 2019

Study Start

April 1, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2022

Last Updated

July 27, 2023

Record last verified: 2020-07

Locations