C.Surgical Procedure; Cardiac Clinical Trial
Official title:
Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial
Verified date | March 2018 |
Source | Instituto do Coracao |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 14 Years |
Eligibility |
Inclusion Criteria: - Elective cardiac surgery with cardiopulmonary bypass - Written informed consent Exclusion Criteria: - Cardiac arrhythmia - Emergency operation - Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min) - Neoplasia - Heart transplant - Participation in another study |
Country | Name | City | State |
---|---|---|---|
Brazil | Incor - Heart Institute - University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto do Coracao |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lactate clearance | ([lactate initial - lactate delayed]/lactate initial) ×100% | at the beginning of surgery up to 24 hours after surgery | |
Secondary | Length of Mechanical ventilation | hours | within 30 days after cardiac surgery | |
Secondary | Vasopressors and inotropic therapy | hours | within 30 days after cardiac surgery | |
Secondary | Cardiac complications | Low cardiac output syndrome , vasoplegia | within 30 days after cardiac surgery | |
Secondary | Renal complications | Assess by pediatric RIFLE | within 30 days after cardiac surgery | |
Secondary | Infection | Pneumonia, bloodstream, urinary, surgical site and/or sepsis | within 30 days after cardiac surgery | |
Secondary | Length of ICU stay | days | within 30 days after cardiac surgery | |
Secondary | Length of hospital stay | days | within 30 days after cardiac surgery |
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