Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach

NCT01844219 | Completed

• 1 other identifier: 2013-03-059-001
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models using a gray zone approach in patients who underwent aortic surgery in our institution.

Conditions

Aortic Surgery; Postoperative Acute Kidney Injury

Keywords

aortic surgery; acute kidney injury; gray zone approach

Outcome Measures

Primary Outcomes (1)

• presence of acute kidney injury

  1. abrupt (within 48 hours) reduction in kidney function currently defined as 2. absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l), 3. a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or 4. a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours)

  within 48 hour after aortic surgery

Secondary Outcomes (2)

• Gray zone range of each risk scoring model

  within 48 hours

• Number of patients in the gray zone

  within 48 hours after aortic surgery

Study Arms (1)

Patients who underwent aortic surgery

Patients who underwent aortic surgery in Samsung Medical Center during the period between 2004 and 2010

Procedure: elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)

Interventions

elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta) PROCEDURE

Also known as: graft interposition of thoracic aorta

Patients who underwent aortic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

You may qualify if:

• Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

You may not qualify if:

• missing laboratory data
• preoperative hemodialysis
• death during or within 48 hours after surgery

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Elective Surgical Procedures; Clonal Hematopoiesis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Hematopoiesis; Cell Differentiation; Cell Physiological Phenomena; Clonal Evolution; Genetic Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (1)