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Clinical Trials/NCT04154007
NCT04154007
Completed
Not Applicable

Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome: Incidence, Risk Factors and Its Impact on the Outcome

Zagazig University1 site in 1 country81 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Zagazig University
Enrollment
81
Locations
1
Primary Endpoint
development of AKI
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Several studies suggested that ARDS may have important adverse effects on renal function, but few studies have specifically addressed the risk factors of AKI and its impact on the outcome in theses patients.

Detailed Description

Acute respiratory distress syndrome is considered an acute diffuse lung injury in which an inciting inflammatory event is followed by hypoxemic respiratory failure. Despite advances in the management of ARDS, the mortality remains high. The LUNG SAFE study reported that hospital mortality was 34.9% in patients with mild ARDS, 40.3% in patients with moderate ARDS, and 46.1% in patients with severe ARDS. Understanding the prognostic factors in ARDS is essential for decreasing its mortality. Acute kidney injury (AKI) is a common and challenging medical condition in critically ill patients, in which there is a sudden renal impairment during hours to days and it is known to be associated with increased mortality .Other adverse outcomes associated with AKI includes chronic kidney disease (CKD) and high cardio-vascular complications. The incidence of AKI in hospitalized adults was reported to be 22% with a mortality rate of 24%. The severity of AKI ranges from stage 1 to stage 3 according to The KDIGO (Kidney Disease: Improving Global Outcomes) system, based on decreased urine output over time, or increases in serum creatinine, or both.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
March 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherif M. S. Mowafy

Lecturer of anesthesia and surgical intensive care

Zagazig University

Eligibility Criteria

Inclusion Criteria

  • Adult Patients (≥18 years old)
  • diagnosis of ARDS according to Berlin definition

Exclusion Criteria

  • Patients with preexisting chronic kidney disease
  • AKI prior to the onset of ARDS

Outcomes

Primary Outcomes

development of AKI

Time Frame: 30 days

AKI was classified based on the worst of either creatinine or urine output criterion as follows: Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output \<0.5 ml/kg per hour for 6 to 12 hours. Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output \<0.5 ml/kg per hour for ≥12 hours. Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of \<0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy.

Secondary Outcomes

  • ICU length of stay.(30 days)
  • Hospital mortality(90 days)
  • hospital length of stay.(90 days)

Study Sites (1)

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