Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

NCT ID: NCT04154007

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-03-30

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.

Conditions

Acute Kidney Injury; Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult Patients who met the diagnosis of ARDS

ARDS patients were followed for the development of AKI during their ICU stay

kidney function tests - urine output

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sherif M. S. Mowafy

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Shebl, MD

Role: STUDY_DIRECTOR

Chest department, Faculty of Medicine, Zagazig University

Lamiaa G Zake, MD

Role: PRINCIPAL_INVESTIGATOR

Chest department, Faculty of Medicine, Zagazig University

Sherif MS Mowafy, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and Surgical Intensive Care department, Faculty of Medicine, Zagazig University

Ayman R Abd El-Hameed, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Internal Medicine department, Faculty of Medicine, Zagazig University

Locations

Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Countries

Egypt

References

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Reference Type: BACKGROUND

PMID: 18434379 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19756503 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 18382186 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Fischer MJ, Brimhall BB, Lezotte DC, Glazner JE, Parikh CR. Uncomplicated acute renal failure and hospital resource utilization: a retrospective multicenter analysis. Am J Kidney Dis. 2005 Dec;46(6):1049-57. doi: 10.1053/j.ajkd.2005.09.006.

Reference Type: BACKGROUND

PMID: 16310570 (View on PubMed)

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.

Reference Type: BACKGROUND

ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

Reference Type: BACKGROUND

PMID: 22797452 (View on PubMed)

Hoste EA, Clermont G, Kersten A, Venkataraman R, Angus DC, De Bacquer D, Kellum JA. RIFLE criteria for acute kidney injury are associated with hospital mortality in critically ill patients: a cohort analysis. Crit Care. 2006;10(3):R73. doi: 10.1186/cc4915. Epub 2006 May 12.

Reference Type: BACKGROUND

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Other Identifiers

5670/17-10-2019

Identifier Type: -

Identifier Source: org_study_id