Determination of Perioperative Acute Kidney Injury Incidence

Intensive Care Unit Syndrome Clinical Trial

Official title:

Perioperative Acute Kidney Injury Incidence and Risk Factors in Non-cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02521350
• Other study ID #: ATADEK 2015-6 /19
• Status: Active, not recruiting
• Phase: N/A
• First received: June 18, 2015
• Last updated: August 10, 2015
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

In the last few years, acute renal injury (AKI) definition has been significantly changed. In the light of the data obtained from multicenter international studies, acute renal injury was redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 % increment of respective basal value of serum creatinine.

In the current study, older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included and cardiovascular and urological surgery patients and patients with known renal insufficiency will be excluded. It was aimed to measure serum creatinine levels in all included patients at baseline and up to 24h after surgery and will be determined acute kidney injury incidence and risk factors according to new criteria.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• older than 40 years

• no gender specified

• patients who will stay at least one night in hospital

• patient with normal renal function

Exclusion Criteria:

• patient with renal dysfunction and cardiovascular, urological surgery patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Intensive Care Unit Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Acibadem University	Acibadem Adana Hospital, Acibadem Ankara Hospital, Acibadem Atakent University Hospital, Acibadem Bursa Hospital, Acibadem Eskisehir Hastanesi, Acibadem Kocaeli Hospital, Fulya Hospital, Kadikoy Hospital, Kayseri Acibadem Hospital, Kozyatagi Acibadem Hospital

References & Publications (2)

Ricci Z, Cruz D, Ronco C. The RIFLE criteria and mortality in acute kidney injury: A systematic review. Kidney Int. 2008 Mar;73(5):538-46. Epub 2007 Dec 26. 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum creatinine levels at 24h after surgery	AKI incidence determination using 50 % or more than 0.3 mg/dL increment of creatinine levels	Serum creatinine levels will be measured at baseline and up to 24h after surgery	No
Primary	Correlation with use of drugs before surgery and serum creatinine level at 24h after surgery		Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated.	No

External Links

•   Guideline for KDIGO