Determination of Perioperative Acute Kidney Injury Incidence

August 10, 2015 updated by: Acibadem University

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
- older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included into our study. And cardiovascular, urological surgery patients and patients with known renal insufficiency will be excluded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in serum creatinine levels at 24h after surgery
Time Frame: Serum creatinine levels will be measured at baseline and up to 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
Correlation with use of drugs before surgery and serum creatinine level at 24h after surgery
Time Frame: Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated.
Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

Acibadem Fulya Hospital
Acibadem Atakent University Hospital
Acıbadem Adana Hospital
Kadikoy Hospital
Acibadem Ankara Hospital
Acibadem Eskişehir Hastanesi
Acibadem Bursa Hospital
Kayseri Acibadem Hospital
Acibadem Kozyatagi Hospital
Acibadem Kocaeli Hospital

Investigators

  • Principal Investigator: Fevzi TORAMAN, Prof.Dr., Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2015-6 /19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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