Clinical trial NCT04154007: Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome
Official title: Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome: Incidence, Risk Factors and Its Impact on the Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Acute Respiratory Distress Syndrome
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-11-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 81 ARDS patients admitted to the Respiratory, Surgical and Internal Medicine Intensive Care unit, Zagazig University Hospitals during the period from September 2017 to March 2019

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.

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

Primary outcomes:
measure: development of AKI
timeFrame: 30 days
Secondary outcomes:
measure: ICU length of stay.
timeFrame: 30 days
measure: hospital length of stay.
timeFrame: 90 days
measure: Hospital mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals
state: Sharkia
Study officials:
affiliation: Chest department, Faculty of Medicine, Zagazig University
name: Eman Shebl, MD
role: STUDY_DIRECTOR
affiliation: Chest department, Faculty of Medicine, Zagazig University
name: Lamiaa G Zake, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesia and Surgical Intensive Care department, Faculty of Medicine, Zagazig University
name: Sherif MS Mowafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Internal Medicine department, Faculty of Medicine, Zagazig University
name: Ayman R Abd El-Hameed, MD
role: PRINCIPAL_INVESTIGATOR
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