Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

Completed

• Conditions: Acute Respiratory Distress Syndrome; Acute Kidney Injury
• Interventions: Diagnostic Test: kidney function tests - urine output

• Registration Number: NCT04154007
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-03
• Last Update Submitted: 2019-11-03
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Patients who met the diagnosis of ARDS	kidney function tests - urine output	ARDS patients were followed for the development of AKI during their ICU stay

Primary Outcome Measures

Name	Time	Method
development of AKI	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 Outcome Measures

Name	Time	Method
ICU length of stay.	30 days	development of AKI affects the ICU stay
Hospital mortality	90 days	the effect of development of AKI on the mortality of ARDS patients
hospital length of stay.	90 days	development of AKI may affect the length of stay in hospital

Trial Locations

Locations (1)

Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals; 🇪🇬 Zagazig, Sharkia, Egypt