Comparison of PRISM III, PIM2 and PELOD Scoring Systems

Congenital Heart Disease Clinical Trial

Official title:

Comparison Of PRISM III, PIM2 And PELOD Scoring Systems In Predicting Mortality For Patients Undergoing Congenital Cardiac Surgery In Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848168
• Other study ID #: Dr. Siyami Ersek TRH
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

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