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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Perioperative Hemodynamic Optimization Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Goal-directed Therapy (GDT) Protocol

Group Type ACTIVE_COMPARATOR

Goal-directed Resuscitation Therapy (GDT)

Intervention Type 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%.

Standard Protocol

Group Type ACTIVE_COMPARATOR

Standard protocol

Intervention Type 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.

Interventions

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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%.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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LiDCO Rapid will be used to calculate CI and SVI.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No