- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04848168
Comparison of PRISM III, PIM2 and PELOD Scoring Systems
September 5, 2022 updated by: Seyma Sayit, Antalya Training and Research Hospital
Comparison Of PRISM III, PIM2 And PELOD Scoring Systems In Predicting Mortality For Patients Undergoing Congenital Cardiac Surgery In Pediatric Intensive Care Unit
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
116
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- siyami ersek TRH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients younger than 18 years of age who had undergone congenital heart surgery
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity
Time Frame: 3 months
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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.
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3 months
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morbidity indicators
Time Frame: 3 months
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Morbidity indicators were determined as the length of ICU stay, total hospital stay, re-intubation, surgical revision, complications and re-admission to the ICU.
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3 months
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clinical outcomes
Time Frame: 3 months
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Clinical outcomes were determined as 7-day mortality and 30-day mortality.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category
Time Frame: 3 months
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STAT category was determined according to the surgical procedure.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
April 9, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 5, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dr. Siyami Ersek TRH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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