NCT02916043

Brief Summary

Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,099

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

September 25, 2016

Last Update Submit

November 13, 2016

Conditions

Acute Kidney Injury

Keywords

acute kidney injurycardiovascular surgerymortality

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    acute kidney injury during postoperative seven days defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria

    postoperative day seven

Secondary Outcomes (1)

  • All-cause mortality

    postoperative seven years

Other Outcomes (3)

  • Postoperative length of hospital stay

    postoperative two month

  • Postoperative length of ICU stay

    postoperative two months

  • Postoperative incidence of complications

    postoperative two months

Study Arms (1)

Cardiovascular surgery with cardiopulmonary bypass

Cardiovascular surgery with cardiopulmonary bypass

Procedure: Cardiovascular surgery with cardiopulmonary bypass

Interventions

Cardiovascular surgery with cardiopulmonary bypassPROCEDURE

Patients who underwent cardiovascular surgery including valve replacement or thoracic aortic surgery with cardiopulmonary bypass

Cardiovascular surgery with cardiopulmonary bypass

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015

You may qualify if:

  • Adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015

You may not qualify if:

  • Missing preoperative serum creatinine (sCr) values
  • Missing preoperative platelet, neutrophil and lymphocyte counts
  • Patients who underwent preoperative hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cardiovascular Surgical ProceduresCardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeExtracorporeal Circulation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 25, 2016

First Posted

September 27, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)