Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

Study 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.

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

Conditions
-----------------
Acute Kidney Injury, Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: kidney function tests - urine output


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult Patients who met the diagnosis of ARDS<br>ARDS patients were followed for the development of AKI during their ICU stay | Diagnostic Test: kidney function tests - urine output<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of AKI | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay. | development of AKI affects the ICU stay | 30 days | 
| hospital length of stay. | development of AKI may affect the length of stay in hospital | 90 days | 
| Hospital mortality | the effect of development of AKI on the mortality of ARDS patients | 90 days |