Acute Kidney InjuryNCT00777465
Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria
An observational study of Acute Kidney Injury, run by Hospital de Base at 1 site in Brazil.
Trial summary
The aim of this study was to apply the acute kidney injury criteria based on KDIGO classification in a population of patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of 30-day mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 2,804 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2003to Jun 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected consecutively after cardiac surgery (CABG or CVS) in a setting of postoperative intensive care unit.
Who may be able to join
- patients undergoing isolated coronary artery bypass grafting or cardiac valve surgery.
Who cannot join
- patients with incomplete data and patients with end-stage kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria
The aim of this study was to apply the acute kidney injury criteria based on KDIGO classification in a population of patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of 30-day mortality.
Read the detailed description
This was a single center study. We evaluated retrospectively patients from the Cardiac Surgery Intensive Care Unit in Hospital de Base, São José do Rio Preto Medical School, São Paulo, Brazil. Demographics, type of surgery, laboratory data and preoperative, perioperative, and postoperative information were retrieved from a prospectively collected database of 2878 patients older than 18 years undergoing isolated CABG (1786) or CVS (1092), from January 2003 to June 2013. After applying the exclusion criteria (51 patients with incomplete data and 23 patients with end-stage kidney disease) we analyzed 2804 patients in total, 1738 (62%) underwent CABG and 1066 (38%) underwent CVS.
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Kidney failure, Risk factors, Clinical outcomes, Cardiac valve surgery, Coronary artery bypass grafting, Morbidity, Mortality
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
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 |
|---|---|---|
| KDIGO 0 | Patients with no acute kidney injury after cardiac surgery | |
| KDIGO 1 | Patients with acute kidney injury KDIGO stage 1 after cardiac surgery (Increase in SCr by ≥ 0.3 mg/dL (≥ 26.5 lmol/L) or 1.5 to 1.9 times baseline) | |
| KDIGO 2 | Patients with acute kidney injury KDIGO stage 2 after cardiac surgery (2.0 to 2.9 times baseline SCr) | |
| KDIGO 3 | Patients with acute kidney injury KDIGO stage 3 after cardiac surgery (3.0 times baseline or more; or increase in SCr to ≥ 4.0 mg/dL; or initiation of renal replacement therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality
To test the hypothesis that the acute kidney injury based on KDIGO criteria after cardiac surgery is a independent predictor of 30-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startJan 2003
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 2,804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio de Nassau Machado, Hospital de Base
- Investigators
- Lilia N Maia, PhD, Study director, São José do Rio Preto Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777465
- Sponsor's protocol ID
- CAAE-3436.0.000.140-08
- Status last verified
- May 2014
- First submitted
- 21 Oct 2008
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria
- ClinicalTrials.gov ID
- NCT00777465
- Acronym / sponsor ID
- CAAE-3436.0.000.140-08
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Kidney failure, Risk factors, Clinical outcomes, Cardiac valve surgery, Coronary artery bypass grafting, Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,804 participants (actual)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Oct 2008 (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.
The aim of this study was to apply the acute kidney injury criteria based on KDIGO classification in a population of patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of 30-day mortality.
Detailed description
This was a single center study. We evaluated retrospectively patients from the Cardiac Surgery Intensive Care Unit in Hospital de Base, São José do Rio Preto Medical School, São Paulo, Brazil. Demographics, type of surgery, laboratory data and preoperative, perioperative, and postoperative information were retrieved from a prospectively collected database of 2878 patients older than 18 years undergoing isolated CABG (1786) or CVS (1092), from January 2003 to June 2013. After applying the exclusion criteria (51 patients with incomplete data and 23 patients with end-stage kidney disease) we analyzed 2804 patients in total, 1738 (62%) underwent CABG and 1066 (38%) underwent CVS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KDIGO 0 | – | –Patients with no acute kidney injury after cardiac surgery |
| KDIGO 1 | – | –Patients with acute kidney injury KDIGO stage 1 after cardiac surgery (Increase in SCr by ≥ 0.3 mg/dL (≥ 26.5 lmol/L) or 1.5 to 1.9 times baseline) |
| KDIGO 2 | – | –Patients with acute kidney injury KDIGO stage 2 after cardiac surgery (2.0 to 2.9 times baseline SCr) |
| KDIGO 3 | – | –Patients with acute kidney injury KDIGO stage 3 after cardiac surgery (3.0 times baseline or more; or increase in SCr to ≥ 4.0 mg/dL; or initiation of renal replacement therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected consecutively after cardiac surgery (CABG or CVS) in a setting of postoperative intensive care unit.
Key inclusion criteria (1 listed)
- patients undergoing isolated coronary artery bypass grafting or cardiac valve surgery.
Key exclusion criteria (1 listed)
- patients with incomplete data and patients with end-stage kidney disease.
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
Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality
Time frame: 30 days
To test the hypothesis that the acute kidney injury based on KDIGO criteria after cardiac surgery is a independent predictor of 30-day mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
Lilia N Maia, PhD study director
São José do Rio Preto Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Hospital de Base at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2014.