Intensive Care Unit SyndromeNCT02521350
Determination of Perioperative Acute Kidney Injury Incidence
An observational study of Intensive Care Unit Syndrome, run by Acibadem University.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Intensive Care Unit Syndrome
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- older than 40 years
- no gender specified
- patients who will stay at least one night in hospital
- patient with normal renal function
Who cannot join
- patient with renal dysfunction and cardiovascular, urological surgery patients
About this study
Official title: 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.
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Acute Kidney Injury, Surgery, Perioperative care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Kadikoy Hospital, Acibadem Atakent University Hospital, Acibadem Fulya Hospital, Acibadem Ankara Hospital, Acibadem Eskişehir Hastanesi, Acibadem Bursa Hospital, Kayseri Acibadem Hospital, Acıbadem Adana Hospital, Acibadem Kozyatagi Hospital, Acibadem Kocaeli Hospital
- Responsible party
- Sponsor
- Investigators
- Fevzi TORAMAN, Prof.Dr., Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521350
- Sponsor's protocol ID
- ATADEK 2015-6 /19
- Status last verified
- Aug 2015
- First submitted
- 18 Jun 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23744003Ricci 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.
PubMed 18160961
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Acute Kidney Injury Incidence and Risk Factors in Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT02521350
- Acronym / sponsor ID
- ATADEK 2015-6 /19
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Acute Kidney Injury, Surgery, Perioperative care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Kadikoy Hospital, Acibadem Atakent University Hospital, Acibadem Fulya Hospital, Acibadem Ankara Hospital, Acibadem Eskişehir Hastanesi, Acibadem Bursa Hospital, Kayseri Acibadem Hospital, Acıbadem Adana Hospital, Acibadem Kozyatagi Hospital, Acibadem Kocaeli Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- older than 40 years
- no gender specified
- patients who will stay at least one night in hospital
- patient with normal renal function
Key exclusion criteria (1 listed)
- patient with renal dysfunction and cardiovascular, urological surgery patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Results publication: PubMed 23744003Susantitaphong 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.
- Results publication: PubMed 18160961Ricci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fevzi TORAMAN, Prof.Dr. principal investigator
Acibadem University
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by Acibadem University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521350, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.