CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 152 enrolled
Drug / intervention
Pediatric cardiac surgery with cardiopulmonary bypassprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05284500
NCT05284500N/ACompleted

Predictive Pre and Peroperative Factors for Multiple Organ Dysfunction Score 2 (MODS-2) in Pediatric Cardiac Surgery

Brugmann University Hospital·observational·Posted Mar 17, 2022·Updated Jul 20, 2022

In Brief

An observational study evaluating Pediatric cardiac surgery with cardiopulmonary bypass for Congenital Heart Disease in Children and 3 related conditions. Completed, enrolled 152 participants across 1 site.

Detailed Summary

Pediatric cardiac surgery has a relatively high morbi-mortality. Despite great advances in surgical techniques, today the mortality rate is about 3% and morbidity is about 30-40%. Outcome has been related to demographic factors, like age; peroperative factors, like duration of cardiopulmonary bypass as well as postoperative factors like positive fluid balance. Willems et al defined a new score (MODS2), an outcome score combining either patient's death or a high postoperative morbidity. This morbidity is defined as minimum of 2 organ failures: either respiratory insufficiency, prolonged use of inotropic agents or renal insufficiency. The aim of this study is to identify pre and peroperative factors which are predictors of MODS2. Patients operated between 2008 and 2018 for pediatric cardiac surgery with cardiopulmonary bypass will be included. Variables extracted from our database will be: sex, ASA score, cyanotic cardiac pathology, redo surgery, RACH1 score, use of antifibrinolytic agents, aortic cross-clamping, deep hypothermic circulatory arrest, selective cerebral perfusion, red cell transfusion in the operating room, administration of fresh frozen plasma in the operating room, age, preoperative weight, weight difference between preop weight and weight at postop day 2, emergency surgery, duration of aortic cross clamping, duration of selective cerebral perfusion, duration of cardiopulmonary bypass, duration off deep hypothermic circulatory arrest, duration of surgery, minimal core temperature, cardiopulmonary priming volume, calculated hemodilution, use of red blood cells in the cardiopulmonary bypass priming, preoperative hemoglobin, preoperative hematocrit, preoperative platelet count, preop international normalized ratio, preop fibrinogen, preop creatinin, toal fluid balance, blood loss during surgery. A statistical analysis (see detailed description) will be used to establish a prediction model for MODS2. The variables describing best the MODS2 outcome will be retained.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 17, 2022
Enrollment StartMar 18, 2022
Primary CompletionJun 30, 2022
Study CompletionJul 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.3 years ago

Interventions

Pediatric cardiac surgery with cardiopulmonary bypassprocedure

All patients undergoing pediatric cardiac surgery with cardiopulmonary bypass will be extracted from our database