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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Ludhmila Abrahão Hajjar, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01470976
First received: October 17, 2011
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Perioperative Hemodynamic Optimization
Cardiac Surgery
Other: Goal-directed Resuscitation Therapy (GDT)
Other: Standard protocol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Composite of death or major postoperative complications [ Time Frame: within 30 days after cardiac surgery ] [ Designated as safety issue: Yes ]
    Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.


Secondary Outcome Measures:
  • Duration of ICU stay and hospital stay. [ Time Frame: within 30 days after cardiac surgery ] [ Designated as safety issue: Yes ]
    To compare the number of days of ICU stay and hospital stay between groups.

  • Tissue hypoperfusion markers [ Time Frame: within 30 days after cardiac surgery ] [ Designated as safety issue: No ]
    To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.

  • Cardiovascular measures [ Time Frame: within 30 days after cardiac surgery ] [ Designated as safety issue: No ]
    To compare levels of BNP, myocardial enzymes, echocardiographic measures and free-days of vasopressors and inotropes between groups.

  • Mechanical ventilation [ Time Frame: within 30 days after cardiac surgery ] [ Designated as safety issue: No ]
    To compare the number of mechanical ventilation free-days between groups.

  • Fluid balance [ Time Frame: during ICU stay ] [ Designated as safety issue: No ]
    To compare fluid balance during ICU stay between groups.


Estimated Enrollment: 144
Study Start Date: November 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Goal-directed Therapy (GDT) Protocol Other: Goal-directed Resuscitation Therapy (GDT)
  • 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 Name: LiDCO Rapid will be used to calculate CI and SVI.
Active Comparator: Standard Protocol Other: Standard protocol
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470976

Locations
Brazil
Instituto do Coracao - InCor / HCFMUSP
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Ludhmila A Hajjar, MD, PhD University of Sao Paulo
  More Information

Publications:
Responsible Party: Ludhmila Abrahão Hajjar, Supervisor of the Surgical Intensive Care Unit of the Heart Institute, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01470976     History of Changes
Other Study ID Numbers: 0565/11
Study First Received: October 17, 2011
Last Updated: May 18, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Goal-directed therapy
Hemodynamic optimization
Cardiac surgery

ClinicalTrials.gov processed this record on October 01, 2014