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

NCT01470976 | Completed Phase 3

• 1 other identifier: 0565/11
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Hemodynamic Optimization; Cardiac Surgery

Keywords

Goal-directed therapy; Hemodynamic optimization; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Composite of death or major postoperative complications

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

  within 30 days after cardiac surgery

Secondary Outcomes (5)

• Duration of ICU stay and hospital stay.

  within 30 days after cardiac surgery

• Tissue hypoperfusion markers

  within 30 days after cardiac surgery

• Cardiovascular measures

  within 30 days after cardiac surgery

• Mechanical ventilation

  within 30 days after cardiac surgery

• Fluid balance

  during ICU stay

Study Arms (2)

Goal-directed Therapy (GDT) Protocol

ACTIVE COMPARATOR

Other: Goal-directed Resuscitation Therapy (GDT)

Standard Protocol

ACTIVE COMPARATOR

Other: Standard protocol

Interventions

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%.

Also known as: LiDCO Rapid will be used to calculate CI and SVI.

Goal-directed Therapy (GDT) Protocol

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.

Standard Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Coracao - InCor / HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (2)

• Hajjar LA, Fukushima JT, Osawa E, Almeida JP, Galas FR. Dobutamine administration in patients after cardiac surgery: beneficial or harmful? Crit Care. 2011;15(5):444. doi: 10.1186/cc10439. Epub 2011 Sep 27. No abstract available.

  PMID: 21958463 BACKGROUND

• Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.

  PMID: 20940381 BACKGROUND

MeSH Terms

Interventions

AIEOP acute lymphoblastic leukemia protocol

Study Officials

• Ludhmila A Hajjar, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor of the Surgical Intensive Care Unit of the Heart Institute

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

BR (1)