AKIN Criteria: Acute Kidney Injury After On-Pump Coronary... | NCT00780845

Studies
AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)

NCT00780845

Sponsor

Hospital de Base

Status

Completed

Last Update Posted

Nov 4, 2008Estimated

Enrollment

817Actual

Phase

Not provided

Conditions

Kidney Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Oct 27, 2008

First Submission Date that Met QC Criteria

Oct 27, 2008

First Posted Date

Oct 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2008

Last Update Posted Date

Nov 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

817Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AKI (-)		Patients without acute kidney injury after on-pump CABG
AKI (+)		Patients with acute kidney injury after on-pump CABG

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality		30 days

Secondary Outcomes

Measure	Description	Time Frame
To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent on-pump coronary artery bypass grafting
Patients with at least two serum creatinine values within 48 hours.

Exclusion Criteria:

Patients with end-stage kidney disease requiring renal replacement therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Groups AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lilia N Maia, PhD	São José do Rio Preto Medical School	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19851652	Derived	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.

ID	Term
D051437	Renal Insufficiency
D058186	Acute Kidney Injury

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications