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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02916043
• Collaborator: (none)
• Enrollment: 1,099
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 156.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Procedure: Cardiovascular surgery with cardiopulmonary bypass

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 Design

• Study Type: Observational
• Actual Enrollment: 1099 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Risk Factor of Acute Kidney Injury After Open Heart Surgery With Cardiopulmonary Bypass
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cardiovascular surgery with cardiopulmonary bypass 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

Outcome Measures

Primary Outcome Measures

1. Acute kidney injury [postoperative day seven]

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

Secondary Outcome Measures

1. All-cause mortality [postoperative seven years]

   all-cause mortality after cardiovascular surgery after postoperative seven years

Other Outcome Measures

1. Postoperative length of hospital stay [postoperative two month]

   postoperative length of hospital stay

2. Postoperative length of ICU stay [postoperative two months]

   postoperative length of ICU stay during postoperative two months

3. Postoperative incidence of complications [postoperative two months]

   postoperative incidences of surgery-related complications during hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02916043
• Other Study ID Numbers: 1604-038-753
• First Posted: Sep 27, 2016
• Last Update Posted: Nov 15, 2016
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital: acute kidney injury; cardiovascular surgery; mortality
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Nov 15, 2016