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Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery

NCT05284500 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease in Children
  • Cardiac Surgical Procedures
  • Outcome Assessment
  • Organ Dysfunction Scores

Interventions

PROCEDURE

Pediatric cardiac surgery with cardiopulmonary bypass

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

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Denis Schmartz, MD · CHU Brugmann

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2022-06-30
Completion
2022-07-08

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05284500 on ClinicalTrials.gov