NCT04848168

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

April 9, 2021

Last Update Submit

September 5, 2022

Conditions

Keywords

PRISM IIIPIM2PELODSTATmortalitycongenital heart disease

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • clinical outcomes

    Clinical outcomes were determined as 7-day mortality and 30-day mortality.

    3 months

Secondary Outcomes (1)

  • to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category

    3 months

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients younger than 18 years of age who had undergone congenital heart surgery

You may qualify if:

  • Patients younger than 18 years of age who had undergone congenital heart surgery

You may not qualify if:

  • emergency operations Patients staying in intensive care unit for less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

siyami ersek TRH

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 19, 2021

Study Start

February 1, 2019

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations