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Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154007
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, 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.

Condition or disease Intervention/treatment
Acute Kidney Injury Acute Respiratory Distress Syndrome Diagnostic Test: kidney function tests - urine output

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.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome: Incidence, Risk Factors and Its Impact on the Outcome
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019


Group/Cohort Intervention/treatment
Adult Patients who met the diagnosis of ARDS
ARDS patients were followed for the development of AKI during their ICU stay
Diagnostic Test: kidney function tests - urine output

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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154007


Locations
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Egypt
Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44111
Sponsors and Collaborators
Zagazig University
Investigators
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Study Director: Eman Shebl, MD Chest department, Faculty of Medicine, Zagazig University
Principal Investigator: Lamiaa G Zake, MD Chest department, Faculty of Medicine, Zagazig University
Principal Investigator: Sherif MS Mowafy, MD Anesthesia and Surgical Intensive Care department, Faculty of Medicine, Zagazig University
Principal Investigator: Ayman R Abd El-Hameed, MD Nephrology Internal Medicine department, Faculty of Medicine, Zagazig University
Publications:
Kidney Disease: Improving global outcomes (KDIGO) acute kidney injury working group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int Suppl (2012). 2012;2(1):1-138.

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Responsible Party: Sherif M. S. Mowafy, Lecturer of anesthesia and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier: NCT04154007    
Other Study ID Numbers: 5670/17-10-2019
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will be available within 6 months after publication
Access Criteria: by contacting the study director

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Acute Kidney Injury
Syndrome
Wounds and Injuries
Disease
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury