NCT02332070

Brief Summary

  1. 1.To examine two main predictor variables independently and then jointly in stratified and multivariate analyses for the outcomes of CSA-AKI, MARCE, need for RRT, and inpatient mortality, and the composite, as well as the outcomes of 30 day rehospitalization or death, and finally for the days out of hospital and alive adjusted to person-year of time
  2. 2.Days from coronary angiogram performed with IOCM to cardiac surgery (1, 2, 3, etc)
  3. 3.Thakar Acute Renal Failure (ARF) score (1 to 17)
  4. 4.To examine the interrelationships between time in days between angiogram and surgery and the ARF Score with the Society of Thoracic Surgery (STS) Risk score for mortality

Trial Health

87
On Track

Trial Health Score

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

Enrollment
965

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

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, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

January 5, 2015

Last Update Submit

February 8, 2018

Conditions

Acute Kidney InjuryRenal Insufficiency

Keywords

acute kidney injurycoronary angiographycardiac surgeryadverse eventsiodinated contrastThoracic Surgery

Outcome Measures

Primary Outcomes (3)

  • Contrast-induced acute kidney injury

    KDIGO definition

    7 days

  • Cardiac surgery associated acute kidney injury

    KDIGO definition

    7 days

  • Major adverse renal and cardiac events

    Composite of need for renal replacement therapy, myocardial infarction, stroke, heart failure, hospitalizations for cardiac reasons, hospitalization for renal reasons, and death

    30 days

Secondary Outcomes (9)

  • Renal replacement therapy

    30 days

  • Myocardial Infarction

    30 days

  • Stroke

    30 days

  • Heart failure

    30 days

  • Hospitalization for renal reasons

    30 days

  • +4 more secondary outcomes

Interventions

cardiac surgeryPROCEDURE

coronary artery bypass surgery and or cardiac valve surgery with cardiopulmonary bypass

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Using the Texas Quality Initiative cardiothoracic surgery database, patients who have recorded one preoperative and at least one baseline and postoperative serum creatinine (mg/dl).

You may qualify if:

  • Cardiac surgery with or without cardiac valve surgery
  • At least one baseline and postoperative serum creatinine (mg/dl)

You may not qualify if:

  • Use of contrast agent other than IOCM with the preoperative angiogram
  • Preoperative use of ventricular assist devices and intraaortic balloon counterpulsation.
  • Operations where there is implantation of mechanical assist devices or cardiac transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Heart and Vascular Institute

Dallas, Texas, 75226, United States

Location

Related Publications (3)

  • McCullough PA, Brown JR. Effects of Intra-Arterial and Intravenous Iso-Osmolar Contrast Medium (Iodixanol) on the Risk of Contrast-Induced Acute Kidney Injury: A Meta-Analysis. Cardiorenal Med. 2011;1(4):220-234. doi: 10.1159/000332384. Epub 2011 Oct 4.

    PMID: 22164156BACKGROUND

  • Chawla LS, Amdur RL, Shaw AD, Faselis C, Palant CE, Kimmel PL. Association between AKI and long-term renal and cardiovascular outcomes in United States veterans. Clin J Am Soc Nephrol. 2014 Mar;9(3):448-56. doi: 10.2215/CJN.02440213. Epub 2013 Dec 5.

    PMID: 24311708BACKGROUND

  • Tecson KM, Brown D, Choi JW, Feghali G, Gonzalez-Stawinski GV, Hamman BL, Hebeler R, Lander SR, Lima B, Potluri S, Schussler JM, Stoler RC, Velasco C, McCullough PA. Major Adverse Renal and Cardiac Events After Coronary Angiography and Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1724-1730. doi: 10.1016/j.athoracsur.2018.01.010. Epub 2018 Feb 2.

    PMID: 29408241RESULT

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2018

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

US(1)