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Trials / Completed

CompletedNCT04154007

Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

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

Status
Completed
Phase
Study type
Observational
Enrollment
81 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
18 Years – 65 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTkidney function tests - urine outputAKI 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.

Timeline

Start date
2017-09-01
Primary completion
2019-03-30
Completion
2019-03-30
First posted
2019-11-06
Last updated
2019-11-06

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04154007. Inclusion in this directory is not an endorsement.