Neutrophil, Lymphocyte and Platelet as a Predictor for AKI and Mortality

November 13, 2016 updated by: Won Ho Kim, MD, Seoul National University Hospital

Risk Factor of Acute Kidney Injury After Open Heart Surgery With Cardiopulmonary Bypass

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury (AKI) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. The incidence of AKI after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (RRT) to be up to 8 %.

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.

Study Type

Observational

Enrollment (Actual)

1099

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiovascular surgery with cardiopulmonary bypass
Procedure: Cardiovascular surgery with cardiopulmonary bypass
Patients who underwent cardiovascular surgery including valve replacement or thoracic aortic surgery with cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: postoperative day seven
acute kidney injury during postoperative seven days defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria
postoperative day seven

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: postoperative seven years
all-cause mortality after cardiovascular surgery after postoperative seven years
postoperative seven years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative length of hospital stay
Time Frame: postoperative two month
postoperative length of hospital stay
postoperative two month
Postoperative length of ICU stay
Time Frame: postoperative two months
postoperative length of ICU stay during postoperative two months
postoperative two months
Postoperative incidence of complications
Time Frame: postoperative two months
postoperative incidences of surgery-related complications during hospital stay
postoperative two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 25, 2016

First Submitted That Met QC Criteria

September 25, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604-038-753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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