Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154007
• Other study ID #: 5670/17-10-2019
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: November 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Egypt	Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View Citation

Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350. — View Citation

Cartin-Ceba R, Haugen EN, Iscimen R, Trillo-Alvarez C, Juncos L, Gajic O. Evaluation of "Loss" and "End stage renal disease" after acute kidney injury defined by the Risk, Injury, Failure, Loss and ESRD classification in critically ill patients. Intensive Care Med. 2009 Dec;35(12):2087-95. doi: 10.1007/s00134-009-1635-9. Epub 2009 Sep 15. — View Citation

Coca SG, Cho KC, Hsu CY. Acute kidney injury in the elderly: predisposition to chronic kidney disease and vice versa. Nephron Clin Pract. 2011;119 Suppl 1:c19-24. doi: 10.1159/000328023. Epub 2011 Aug 10. Review. — View Citation

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. — View Citation

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. Epub 2006 May 12. — View Citation

Hoste EA, Schurgers M. Epidemiology of acute kidney injury: how big is the problem? Crit Care Med. 2008 Apr;36(4 Suppl):S146-51. doi: 10.1097/CCM.0b013e318168c590. Review. — View Citation

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.

Peter JV, John P, Graham PL, Moran JL, George IA, Bersten A. Corticosteroids in the prevention and treatment of acute respiratory distress syndrome (ARDS) in adults: meta-analysis. BMJ. 2008 May 3;336(7651):1006-9. doi: 10.1136/bmj.39537.939039.BE. Epub 2008 Apr 23. Review. — View Citation

Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10.2215/CJN.00710113. Epub 2013 Jun 6. Erratum in: Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1148. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ICU length of stay.	development of AKI affects the ICU stay	30 days
Secondary	hospital length of stay.	development of AKI may affect the length of stay in hospital	90 days
Secondary	Hospital mortality	the effect of development of AKI on the mortality of ARDS patients	90 days