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NCT Number: NCT04154007

Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Acute Kidney Injury Acute Respiratory Distress Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lung Diseases Male Urogenital Diseases Renal Insufficiency Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals

Zagazig, Sharqia Province, 44111, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

kidney function tests - urine output

Diagnostic Test

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.

Primary outcomes

  1. 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

  1. ICU length of stay.

    Time frame: 30 days

    development of AKI affects the ICU stay

  2. hospital length of stay.

    Time frame: 90 days

    development of AKI may affect the length of stay in hospital

  3. Hospital mortality

    Time frame: 90 days

    the effect of development of AKI on the mortality of ARDS patients

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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