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NCT Number: NCT03469440

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

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

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Key information

Conditions

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

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

Location status: Recruiting

Location contact

Filomena RG Galas

CONTACT

[email protected]

+551126615232

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous central venous oxygenation monitoring

Other

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

Other

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.

Primary outcomes

  1. Lactate clearance

    Time frame: at the beginning of surgery up to 24 hours after surgery

    ([lactate initial - lactate delayed]/lactate initial) ×100%

Secondary outcomes

  1. Length of Mechanical ventilation

    Time frame: within 30 days after cardiac surgery

    hours

  2. Vasopressors and inotropic therapy

    Time frame: within 30 days after cardiac surgery

    hours

  3. Cardiac complications

    Time frame: within 30 days after cardiac surgery

    Low cardiac output syndrome , vasoplegia

  4. Renal complications

    Time frame: within 30 days after cardiac surgery

    Assess by pediatric RIFLE

  5. Infection

    Time frame: within 30 days after cardiac surgery

    Pneumonia, bloodstream, urinary, surgical site and/or sepsis

  6. Length of ICU stay

    Time frame: within 30 days after cardiac surgery

    days

  7. Length of hospital stay

    Time frame: within 30 days after cardiac surgery

    days

Study contacts

Contact information is provided by the study sponsor or research team.

Filomena G Galas, Phd

CONTACT

[email protected]

+55 11 99319-0441

Sponsors and collaborators

Lead sponsor

Instituto do Coracao

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2018
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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