NCT00780845

Brief Summary

The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
817

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
Last Updated

November 4, 2008

Status Verified

October 1, 2008

Enrollment Period

5 years

First QC Date

October 27, 2008

Last Update Submit

November 3, 2008

Conditions

Kidney Failure

Keywords

Acute Kidney failureClinical outcomesOn-pumpCoronary artery bypass graftingMorbidityMortality

Outcome Measures

Primary Outcomes (1)

  • To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality

    30 days

Secondary Outcomes (1)

  • To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG

    30 days

Study Arms (2)

AKI (-)

Patients without acute kidney injury after on-pump CABG

AKI (+)

Patients with acute kidney injury after on-pump CABG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19851652DERIVED

MeSH Terms

Conditions

Renal InsufficiencyAcute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Lilia N Maia, PhD

    São José do Rio Preto Medical School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

January 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 4, 2008

Record last verified: 2008-10