Clinical trial NCT02521350: Determination of Perioperative Acute Kidney Injury Incidence
Official title: Perioperative Acute Kidney Injury Incidence and Risk Factors in Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Unit Syndrome
Keywords: Acute Kidney Injury
Surgery
Perioperative care
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Kadikoy Hospital
name: Acibadem Atakent University Hospital
name: Acibadem Fulya Hospital
name: Acibadem Ankara Hospital
name: Acibadem Eskişehir Hastanesi
name: Acibadem Bursa Hospital
name: Kayseri Acibadem Hospital
name: Acıbadem Adana Hospital
name: Acibadem Kozyatagi Hospital
name: Acibadem Kocaeli Hospital
First posted: 2015-08-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: older than 40 years, no gender specified, patients who will stay at least one night in hospital except cardiovascular, urological surgery and known renal insufficiency.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in serum creatinine levels at 24h after surgery
timeFrame: Serum creatinine levels will be measured at baseline and up to 24h after surgery
measure: Correlation with use of drugs before surgery and serum creatinine level at 24h after surgery
timeFrame: Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Acibadem University
name: Fevzi TORAMAN, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1038/sj.ki.5002743. Epub 2007 Dec 26.