Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469440
• Other study ID #: 3988.13.113
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2018
• Last updated: March 15, 2018
• Start date: February 1, 2018
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Instituto do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.

Description:

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac
• Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention

Other:
• Continuous central venous oxygenation monitoring
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.
• Standard protocol
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.

Locations

Country	Name	City	State
Brazil	Incor - Heart Institute - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

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