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NCT03513718 Clinical Trial

Acute Kidney Injury After Cardiac Surgery on CPB

Surgery Clinical Trial

Official title:
Incidence of Acute Kidney Injury After Cardiac Surgery on Cardiopulmonary Bypass in the Pediatric Intensive Care Unit of Lausanne. A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03513718
Other study ID # 2017-01542
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date September 5, 2023

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.

Description:

The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date September 5, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 16 Years
Eligibility Inclusion Criteria: - all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB. Exclusion Criteria: - Preexisting kidney injury, - no preoperative creatinine lab value

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland CHUV Lausanne Vaud

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence and severity of an AKI occurring during stay in the PICU Scoring AKI with pRiffle up to 3 month
Secondary PICU stay and ventilation time correlation between AKI and invasive ventilation/duration and PICU stay up to 3 month
Secondary Persisting AKI after release from PICU according to RIFLE score After leaving ICU more than 3 month
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