Kidney FailureNCT00780845
AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)
An observational study of Kidney Failure, run by Hospital de Base.
Trial summary
The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- How many people
- 817 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jan 2008
- 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: Groups AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit
Who may be able to join
- Patients underwent on-pump coronary artery bypass grafting
- Patients with at least two serum creatinine values within 48 hours.
Who cannot join
- Patients with end-stage kidney disease requiring renal replacement therapy.
About this study
Official title: AKIN (Acute Kidney Injury Network): Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft Surgery
The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.
Read the detailed description
Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG. Group AKI (+) - patients with acute kidney injury after on-pump CABG. AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline). The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU. Clinical Outcomes and 30-day mortality was evaluate in this patients.
- Conditions
- Kidney Failure
- Keywords
- Acute Kidney failure, Clinical outcomes, On-pump, Coronary artery bypass grafting, Morbidity, Mortality
- Medical subject headings
- Renal Insufficiency, 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 |
|---|---|---|
| AKI (-) | Patients without acute kidney injury after on-pump CABG | |
| AKI (+) | Patients with acute kidney injury after on-pump CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality
Measured: 30 days
Secondary outcomes (1)
To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG
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 posted28 Oct 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies 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
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Investigators
- Lilia N Maia, PhD, Study director, São José do Rio Preto Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780845
- Sponsor's protocol ID
- CAAE-3438.0.000.140-08
- Status last verified
- Oct 2008
- First submitted
- 27 Oct 2008
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Machado MN, Miranda RC, Takakura IT, Palmegiani E, Santos CA, Oliveira MA, Mouco OM, Hernandes ME, Lemos MA, Maia LN. Acute kidney injury after on-pump coronary artery bypass graft surgery. Arq Bras Cardiol. 2009 Sep;93(3):247-52. doi: 10.1590/s0066-782x2009000900008. English, Portuguese, Spanish.
PubMed 19851652
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AKIN (Acute Kidney Injury Network): Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT00780845
- Acronym / sponsor ID
- CAAE-3438.0.000.140-08
- Conditions
- Kidney Failure
- Keywords
- Acute Kidney failure, Clinical outcomes, On-pump, Coronary artery bypass grafting, Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 28 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 purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.
Detailed description
Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG. Group AKI (+) - patients with acute kidney injury after on-pump CABG. AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline). The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU. Clinical Outcomes and 30-day mortality was evaluate in this patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI (-) | – | –Patients without acute kidney injury after on-pump CABG |
| AKI (+) | – | –Patients with acute kidney injury after on-pump CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Groups AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit
Key inclusion criteria (2 listed)
- Patients underwent on-pump coronary artery bypass grafting
- Patients with at least two serum creatinine values within 48 hours.
Key exclusion criteria (1 listed)
- Patients with end-stage kidney disease requiring renal replacement therapy.
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
To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality
Time frame: 30 days
1 secondary outcome
To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG
Time frame: 30 days
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 4 Nov 2008.
- Derived from this study: PubMed 19851652Machado MN, Miranda RC, Takakura IT, Palmegiani E, Santos CA, Oliveira MA, Mouco OM, Hernandes ME, Lemos MA, Maia LN. Acute kidney injury after on-pump coronary artery bypass graft surgery. Arq Bras Cardiol. 2009 Sep;93(3):247-52. doi: 10.1590/s0066-782x2009000900008. English, Portuguese, Spanish.
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, run by Hospital de Base.
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 2 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 4 Nov 2008. 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?
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?
To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 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?
On the ClinicalTrials.gov record for NCT00780845, which also lists 1 linked publication.
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 4 Nov 2008.