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Transition of Acute Kidney Injury to Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT04101110
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa A Mohammed, Assiut University

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.


Condition or disease Intervention/treatment
Acute Kidney Injury Other: Renal biopsy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiology, Risk Factors and Outcomes of Transition of Acute Kidney Injury to Chronic Kidney Disease in Critically Ill Patients
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


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


Primary Outcome Measures :
  1. Incidence of chronic kidney disease [ Time Frame: Baseline ]
    Incidence of chronic kidney disease defined by a decreased glomerular filtration rate under 60 mL/minute/1.73m2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients attending Assiut university hospitals critical care unit and developing acute kidney injury during their stay.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101110


Contacts
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Contact: Mohammed Hossam Eldein Hassan, Professor 00201006261166 Hossammagharby@yahoo.com
Contact: Marwa Kamal Abdo, Assistant professor 00201097878113 Marwa.Kamal82@hotmail.com

Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: Asmaa A Mohammed, Prinsipal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04101110    
Other Study ID Numbers: EROT
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Wounds and Injuries
Urologic Diseases
Renal Insufficiency