Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery (GRICS)

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Cardiac Surgery; Perioperative Hemodynamic Optimization

Treatments: Other: Goal-directed Resuscitation Therapy (GDT); Other: Standard protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01470976

0565/11

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Goal-directed Therapy (GDT) Protocol

Active Comparator group

Treatment:

Other: Goal-directed Resuscitation Therapy (GDT)

Standard Protocol

Active Comparator group

Treatment:

Other: Standard protocol