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

NCT05284500 | Completed

• 1 other identifier: FPMODS2
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• MODS2

  Occurence of MODS2 (as percentage) will be extracted. A predictive model will be established from the observed preoperative and peroperative variables. 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.

  28 days

Study Arms (1)

Pediatric cardiac surgery patients

Patients undergoing pediatric cardiac surgery with cardiopulmonary bypass between 2008 and 2018 at our institution.

Procedure: Pediatric cardiac surgery with cardiopulmonary bypass

Interventions

Pediatric cardiac surgery with cardiopulmonary bypass PROCEDURE

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

Pediatric cardiac surgery patients

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing pediatric cardiac surgery with cardiopulmonary bypass between 2008 and 2018 at our institution

You may qualify if:

• patients undergoing pediatric cardiac surgery with cardiopulmonary bypass between 2008 and 2018 at our institution
• accepting blood transfusions
• ASA score 1-4

You may not qualify if:

• Jehova's witness
• ASA 5 status

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Related Publications (13)

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  PMID: 11782764 BACKGROUND

• Agarwal HS, Wolfram KB, Saville BR, Donahue BS, Bichell DP. Postoperative complications and association with outcomes in pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2014 Aug;148(2):609-16.e1. doi: 10.1016/j.jtcvs.2013.10.031. Epub 2013 Nov 23.

  PMID: 24280709 BACKGROUND

• Wilder NS, Yu S, Donohue JE, Goldberg CS, Blatt NB. Fluid Overload Is Associated With Late Poor Outcomes in Neonates Following Cardiac Surgery. Pediatr Crit Care Med. 2016 May;17(5):420-7. doi: 10.1097/PCC.0000000000000715.

  PMID: 27028790 BACKGROUND

• Willems A, Van Lerberghe C, Gonsette K, De Ville A, Melot C, Hardy JF, Van der Linden P. The indication for perioperative red blood cell transfusions is a predictive risk factor for severe postoperative morbidity and mortality in children undergoing cardiac surgery. Eur J Cardiothorac Surg. 2014 Jun;45(6):1050-7. doi: 10.1093/ejcts/ezt548. Epub 2014 Jan 14.

  PMID: 24431174 BACKGROUND

• Baltsavias I, Faraoni D, Willems A, El Kenz H, Melot C, De Hert S, Van der Linden P. Blood storage duration and morbidity and mortality in children undergoing cardiac surgery. A retrospective analysis. Eur J Anaesthesiol. 2014 Jun;31(6):310-6. doi: 10.1097/EJA.0000000000000024.

  PMID: 24492183 BACKGROUND

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  PMID: 33721876 BACKGROUND

• Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995 Oct;23(10):1638-52. doi: 10.1097/00003246-199510000-00007.

  PMID: 7587228 BACKGROUND

• Slater A, Shann F, Pearson G; Paediatric Index of Mortality (PIM) Study Group. PIM2: a revised version of the Paediatric Index of Mortality. Intensive Care Med. 2003 Feb;29(2):278-85. doi: 10.1007/s00134-002-1601-2. Epub 2003 Jan 23.

  PMID: 12541154 BACKGROUND

• Slater A, Shann F; ANZICS Paediatric Study Group. The suitability of the Pediatric Index of Mortality (PIM), PIM2, the Pediatric Risk of Mortality (PRISM), and PRISM III for monitoring the quality of pediatric intensive care in Australia and New Zealand. Pediatr Crit Care Med. 2004 Sep;5(5):447-54. doi: 10.1097/01.PCC.0000138557.31831.65.

  PMID: 15329160 BACKGROUND

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  PMID: 19630781 BACKGROUND

MeSH Terms

Interventions

Cardiopulmonary Bypass

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Denis Schmartz, MD

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Anesthesiology, Brugmlann University hospital & HUDERF

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: March 18, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 8, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)