Congenital Heart DiseaseNCT04848168
Comparison of PRISM III, PIM2 and PELOD Scoring Systems
An observational study of Congenital Heart Disease, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 May 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
Study population: Patients younger than 18 years of age who had undergone congenital heart surgery
Who may be able to join
- Patients younger than 18 years of age who had undergone congenital heart surgery
Who cannot join
- emergency operations Patients staying in intensive care unit for less than 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Congenital Heart Disease
- Keywords
- PRISM III, PIM2, PELOD, STAT, mortality, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
clinical outcomes
Clinical outcomes were determined as 7-day mortality and 30-day mortality.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Feb 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Haydarpasa Numune Training and Research Hospital
- Responsible party
- Principal investigator, Seyma Sayit, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848168
- Sponsor's protocol ID
- Dr. Siyami Ersek TRH
- Status last verified
- Sep 2022
- First submitted
- 9 Apr 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04848168
- Acronym / sponsor ID
- Dr. Siyami Ersek TRH
- Conditions
- Congenital Heart Disease
- Keywords
- PRISM III, PIM2, PELOD, STAT, mortality, congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Haydarpasa Numune Training and Research Hospital
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients younger than 18 years of age who had undergone congenital heart surgery
Key inclusion criteria (1 listed)
- Patients younger than 18 years of age who had undergone congenital heart surgery
Key exclusion criteria (1 listed)
- emergency operations Patients staying in intensive care unit for less than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity
Time frame: 3 months
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.
morbidity indicators
Time frame: 3 months
Morbidity indicators were determined as the length of ICU stay, total hospital stay, re-intubation, surgical revision, complications and re-admission to the ICU.
clinical outcomes
Time frame: 3 months
Clinical outcomes were determined as 7-day mortality and 30-day mortality.
1 secondary outcome
to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.