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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04848168
Other study ID # Dr. Siyami Ersek TRH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date May 1, 2019

Study information

Verified date September 2022
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

PRISMIII(Pediatric Risk of Mortality III), PIM2(Pediatric Index of Mortality 2) and PELOD(Pediatric Logistic Organ Dysfunction) are frequently used for predicting mortality and morbidity in general pediatric ICUs(Intensive Care Units). However, the effectiveness of these scoring sistems in a specific group patients undergoing congenital heart surgery(CHS) is unknown. In this study, the investigators aimed primarily to evaluate the success of these scoring systems in predicting mortality and morbiditiy in this specific group and to compare the scoring systems with eachother, and secondly to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: - Patients younger than 18 years of age who had undergone congenital heart surgery Exclusion Criteria: - emergency operations Patients staying in intensive care unit for less than 24 hours

Study Design


Locations

Country Name City State
Turkey siyami ersek TRH Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Antalya Training and Research Hospital Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity Patients younger than 18 years of age who had undergone congenital heart surgery were evaluated on the first postoperative day in the ICU and parameters were recorded. PRISMIII and PELOD scores were calculated using the most abnormal values in the first 24 hours, and PIM2 score was calculated using the data within the first hour. 3 months
Primary morbidity indicators Morbidity indicators were determined as the length of ICU stay, total hospital stay, re-intubation, surgical revision, complications and re-admission to the ICU. 3 months
Primary clinical outcomes Clinical outcomes were determined as 7-day mortality and 30-day mortality. 3 months
Secondary to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category STAT category was determined according to the surgical procedure. 3 months
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