Perioperative Hemodynamic OptimizationPhase 3GRICSNCT01470976
Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
A Phase 3 study testing Goal-directed Resuscitation Therapy (GDT) and Standard protocol in people with Perioperative Hemodynamic Optimization and Cardiac Surgery, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hemodynamic Optimization, Cardiac Surgery
- What is being tested?
- Goal-directed Resuscitation Therapy (GDT) and Standard protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 18 years
- Infectious endocarditis
- Transplant procedures
- Emergency procedures
- Pulmonary hypertension
- Preoperative cardiogenic shock or use of dobutamine
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coracao - InCor / HCFMUSP
São Paulo, São Paulo, 05403000
About this study
Official title: Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
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.
- Being tested
- Goal-directed Resuscitation Therapy (GDT), Standard protocol
- Keywords
- Goal-directed therapy, Hemodynamic optimization, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed Resuscitation Therapy (GDT)Other
Also called LiDCO Rapid will be used to calculate CI and SVI.
- 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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed Therapy (GDT) Protocol | Active comparator | Not described Receives: Other: Goal-directed Resuscitation Therapy (GDT) |
| Standard Protocol | Active comparator | Not described Receives: Other: Standard protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after cardiac surgery
Secondary outcomes (5)
Duration of ICU stay and hospital stay.
To compare the number of days of ICU stay and hospital stay between groups.
Measured: within 30 days after cardiac surgery
Tissue hypoperfusion markers
To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.
Measured: within 30 days after cardiac surgery
Cardiovascular measures
To compare levels of BNP, myocardial enzymes, echocardiographic measures and free-days of vasopressors and inotropes between groups.
Measured: within 30 days after cardiac surgery
Mechanical ventilation
To compare the number of mechanical ventilation free-days between groups.
Measured: within 30 days after cardiac surgery
Fluid balance
To compare fluid balance during ICU stay between groups.
Measured: during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative Hemodynamic OptimizationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ludhmila Abrahão Hajjar, University of Sao Paulo
- Investigators
- Ludhmila A Hajjar, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470976
- Sponsor's protocol ID
- 0565/11
- Acronym
- GRICS
- Status last verified
- Feb 2016
- First submitted
- 17 Oct 2011
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21958463Hajjar 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.
PubMed 20940381
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01470976
- Acronym / sponsor ID
- GRICS / 0565/11
- Keywords
- Goal-directed therapy, Hemodynamic optimization, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed Therapy (GDT) Protocol | Active comparator | Other: Goal-directed Resuscitation Therapy (GDT) |
| Standard Protocol | Active comparator | Other: Standard protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (11 listed)
- Age less than 18 years
- Infectious endocarditis
- Transplant procedures
- Emergency procedures
- Pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-directed Resuscitation Therapy (GDT)Also: LiDCO Rapid will be used to calculate CI and SVI.* 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 | Goal-directed Therapy (GDT) Protocol |
| Standard protocolThe 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. | Other | Standard Protocol |
Primary outcome
Composite of death or major postoperative complications
Time frame: 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.
5 secondary outcomes
Duration of ICU stay and hospital stay.
Time frame: within 30 days after cardiac surgery
Tissue hypoperfusion markers
Time frame: within 30 days after cardiac surgery
Cardiovascular measures
Time frame: within 30 days after cardiac surgery
Mechanical ventilation
Time frame: within 30 days after cardiac surgery
Fluid balance
Time frame: during ICU stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Background: PubMed 21958463Hajjar 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.
- Background: PubMed 20940381Hajjar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludhmila A Hajjar, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goal-directed Resuscitation Therapy (GDT) and Standard protocol in people with Perioperative Hemodynamic Optimization and Cardiac Surgery, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death or major postoperative complications (time frame: within 30 days after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470976, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.