Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04101110
Other study ID # EROT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 1, 2022

Study information

Verified date July 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Acute kidney injury is a life threatening and disabling complication of critical illness encountered in 25 -50%h of intensive care unit admission.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 like cardiovascular disease,chronic kidney disease and subsequent progression to end stage renal disease.Several studies have suggested a causal link between acute kidney injury and the consequent development of chronic kidney disease.the severity,frequency and duration of acute kidney injury are key factors in this process. The precise mechanism of transition of acute kidney injury to chronic kidney disease is complex and not completely understood,especially in humans and several pathways have been proposed. Different animal studies have used ischemia-reperfusion and nephrotoxic injuries to investigate the pathophysiologic event involved in acute kidney injury to chronic kidney disease transition ,mainly focusing in the development of specific histological changes .Acute kidney injury outcomes depend, at the tissue level,upon the balance of adaptive and maladaptive repair. An adaptive response to injury usually leads to renal recovery with a complete resolution of pathological changes during acute kidney injury episode(resolution of inflammatory cell infiltration, regeneration of tubular cells,decrease in biomarkers of injury )without long term consequences .However,severe and repeated injury can result in a maladaptive repair,characterized by a permanent reduction in kidney function associated with significant structural changes (persistent expression of pro-fibrotic factors and development of interstitial fibrosis, delayed resolution of inflammation,permanent cell cycle arrest of tubular cells, microvascular rarefaction,renin angiotensin system activation). The incidence rate of renal progression following acute kidney injury has been estimated to be 4.9 events /100 patient-year and is particularly increase in elderly.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date December 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - patients =18 years; - patients suffering an acute kidney injury (defined by Acute kidney injury network (AKIN) score =1)during ICU stay. Exclusion Criteria: - patients <18 years; - pregnant woman; - End stage renal disease (ESRD)prior to ICU admission; - Refusal to participate in the study.

Study Design


Intervention

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

Locations

Country Name City State
Egypt Assiut university hospitals Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of chronic kidney disease Incidence of chronic kidney disease defined by a decreased glomerular filtration rate under 60 mL/minute/1.73m2 Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05538351 - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03938038 - Guidance of Ultrasound in Intensive Care to Direct Euvolemia N/A
Recruiting NCT05805709 - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial N/A
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting NCT05897840 - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients N/A
Recruiting NCT04986137 - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Terminated NCT04293744 - Acute Kidney Injury After Cardiac Surgery N/A
Completed NCT04095143 - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting NCT06064305 - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated NCT03438877 - Intensive Versus Regular Dosage For PD In AKI. N/A
Terminated NCT03305549 - Recovery After Dialysis-Requiring Acute Kidney Injury N/A
Completed NCT05990660 - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery N/A
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated NCT02860130 - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT) Phase 3
Completed NCT06000098 - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting NCT05548725 - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed NCT02665377 - Prevention of Akute Kidney Injury, Hearttransplant, ANP Phase 3
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A