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Completed

NCT Number: NCT01470976

Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

The primary aim of the study is to investigate whether a goal-directed resuscitation therapy in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces complications after cardiac surgery. The hypothesis is that there are better outcomes when achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate higher than 1.5 mmol/L.

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Key information

Conditions

Perioperative Hemodynamic Optimization Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto do Coracao - InCor / HCFMUSP

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
  • Adults patients
  • Written informed consent
  • One of the following criteria:
  • EuroSCORE (European System for Cardiac Operative Risk Evaluation) higher than or equal to 6
  • Ejection fraction lower than 50%
  • Recent myocardial infarction
  • Unstable angina

Exclusion criteria

  • Age less than 18 years
  • Infectious endocarditis
  • Transplant procedures
  • Emergency procedures
  • Pulmonary hypertension
  • Preoperative cardiogenic shock or use of dobutamine
  • Congenital procedures
  • Need for intra-aortic balloon pump (IABP)
  • Noradrenaline dose higher than 1mcg/kg/min
  • Pregnancy
  • Patients who refused participation in the study

Treatment and study plan

Goal-directed Resuscitation Therapy (GDT)

Other
  • A target value of a cardiac index (CI) greater than 3.0 L/min/m2 will be sought.
  • The first step will be fluid resuscitation with 250ml aliquots of Lactated Ringer's solution whenever the CI is lower than 3,0 L/min/m2 and systolic volume index (SVI) is lower than 35ml/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period.
  • When the CI is lower than or equal to 3,0L/min/m2 and SVI higher than or equal to 35 ml/m2, dobutamine will be initiated with increasing doses up to 20mcg/kg/min.
  • The final step will be red blood transfusion to reach a hematocrit higher than 28%.

Other names: LiDCO Rapid will be used to calculate CI and SVI.

Standard protocol

Other

The control group will be managed by the anesthetic team in the operative room and by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.

Primary outcomes

  1. Composite of death or major postoperative complications

    Time frame: within 30 days after cardiac surgery

    Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.

Secondary outcomes

  1. Duration of ICU stay and hospital stay.

    Time frame: within 30 days after cardiac surgery

    To compare the number of days of ICU stay and hospital stay between groups.

  2. Tissue hypoperfusion markers

    Time frame: within 30 days after cardiac surgery

    To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.

  3. Cardiovascular measures

    Time frame: within 30 days after cardiac surgery

    To compare levels of BNP, myocardial enzymes, echocardiographic measures and free-days of vasopressors and inotropes between groups.

  4. Mechanical ventilation

    Time frame: within 30 days after cardiac surgery

    To compare the number of mechanical ventilation free-days between groups.

  5. Fluid balance

    Time frame: during ICU stay

    To compare fluid balance during ICU stay between groups.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

Acronym: GRICS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2011
Registry last updated
Feb 4, 2016

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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