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

Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: C.Surgical Procedure; Cardiac; Heart; Dysfunction Postoperative, Cardiac Surgery
• Intervention / Treatment: Other: Continuous central venous oxygenation monitoring; Other: Standard protocol

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Recruiting
    • Incor - Heart Institute - University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Goal-directed therapy; 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; 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.
OTHER: Standard protocol; The control group will keep the standard therapy.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate clearance	([lactate initial - lactate delayed]/lactate initial) ×100%	at the beginning of surgery up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Mechanical ventilation	hours	within 30 days after cardiac surgery
Vasopressors and inotropic therapy	hours	within 30 days after cardiac surgery
Cardiac complications	Low cardiac output syndrome , vasoplegia	within 30 days after cardiac surgery
Renal complications	Assess by pediatric RIFLE	within 30 days after cardiac surgery
Infection	Pneumonia, bloodstream, urinary, surgical site and/or sepsis	within 30 days after cardiac surgery
Length of ICU stay	days	within 30 days after cardiac surgery
Length of hospital stay	days	within 30 days after cardiac surgery

Collaborators and Investigators

• Sponsor: Instituto do Coracao

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: lactate; Pediatric Cardiac Surgery; central venous saturation
• Other Study ID Numbers: 3988.13.113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No