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

Phase 3

Completed

• Conditions: Perioperative Hemodynamic Optimization; Cardiac Surgery
• Interventions: Other: Goal-directed Resuscitation Therapy (GDT); Other: Standard protocol

• Registration Number: NCT01470976
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-10-17
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Primary Completion: 2014-02
• Study Completion: 2014-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Goal-directed Therapy (GDT) Protocol	Goal-directed Resuscitation Therapy (GDT)	-
Standard Protocol	Standard protocol	-

Primary Outcome Measures

Name	Time	Method
Composite of death or major postoperative complications	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 Outcome Measures

Name	Time	Method
Fluid balance	during ICU stay	To compare fluid balance during ICU stay between groups.
Mechanical ventilation	within 30 days after cardiac surgery	To compare the number of mechanical ventilation free-days between groups.
Cardiovascular measures	within 30 days after cardiac surgery	To compare levels of BNP, myocardial enzymes, echocardiographic measures and free-days of vasopressors and inotropes between groups.
Duration of ICU stay and hospital stay.	within 30 days after cardiac surgery	To compare the number of days of ICU stay and hospital stay between groups.
Tissue hypoperfusion markers	within 30 days after cardiac surgery	To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.

Trial Locations

Locations (1)

Instituto do Coracao - InCor / HCFMUSP; 🇧🇷 Sao Paulo, Brazil