An interventional study of Continuous central venous oxygenation monitoring and Standard protocol in Heart; Dysfunction Postoperative, Cardiac Surgery and C.Surgical Procedure; Cardiac, sponsored by Instituto do Coracao. Recruiting at 1 site in Brazil. Open to participants aged Up to 14 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Instituto do Coracao · Not applicable, Interventional, and Treatment
The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
Pediatric patients undergoing cardiac surgery are at risk for adverse clinical outcomes due a inadequate tissue perfusion. Recent studies have been demonstraded which the monitorization of continuos central venous saturation could be benneficial. There is evidence that monitoring continues venous oxygen saturation (ScvO2) can be beneficial in patient outcomes, guided by ScvO2 therapy has been associated with improved outcomes in resuscitation of critically ill patients with sepsis and after congenital heart surgery complexa. The early detection and treatment of tissue hypoxia can prevent morbidity and mortality. tissue hypoxia may be a result of the imbalance between supply (DO2) and oxygen consumption (VO2). If the fault supply, oxygen consumption is maintained by increased oxygen extraction resulting in decreased central venous oxygen saturation
Instituto do Coracao is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this group will be monitoring by continuous central venous oxygen saturation. Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic.
Other: Continuous central venous oxygenation monitoring
The control group will keep the standard therapy.
Other: Standard protocol
Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic. * First, isotonic crystalloid, 10 up to 20 mL/kg, will be administered in boluses to achieve continuous central venous oxygen saturation higher than 65% in non-cyanogenic and 55% in cyanogenic. * Second, if not achieved with fluid administration, will be targeted by initiating and titrating inotropics (dobutamine or milrinone). If the mean arterial pressure is lower than 50 mm Hg will be associated epinephrine. * If the ScvO2 is lower than 65% in non-cyanogenic and 55% in cyanogenic and the hemoglobin was lower than 8g/dl, red blood cells (20mL/Kg) will be transfused to achieve a hemoglobin level of at least 8g/dL.
The control group will keep the standard therapy to achieve mean arterial pressure higher than 50mmHg, central venous pressure 8 to 12 mmHg, urinay debit higher than 0,5ml/kg/h, hemoglobin higher or equal than 8g/dL, arterial oxygen saturation higher or equal than 92% in non-cyanogenic and 80% cyanogenic, central venous oxygen saturation higher or equal than 65% in non-cyanogenic and 55% in cyanogenic.
Lactate clearance
(\[lactate initial - lactate delayed\]/lactate initial) ×100%
Time frame: at the beginning of surgery up to 24 hours after surgery
Length of Mechanical ventilation
hours
Time frame: within 30 days after cardiac surgery
Vasopressors and inotropic therapy
hours
Time frame: within 30 days after cardiac surgery
Cardiac complications
Low cardiac output syndrome , vasoplegia
Time frame: within 30 days after cardiac surgery
Renal complications
Assess by pediatric RIFLE
Time frame: within 30 days after cardiac surgery
Infection
Pneumonia, bloodstream, urinary, surgical site and/or sepsis
Time frame: within 30 days after cardiac surgery
Length of ICU stay
days
Time frame: within 30 days after cardiac surgery
Length of hospital stay
days
Time frame: within 30 days after cardiac surgery
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Dec 2024, 82 months after the start.
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Instituto do Coracao