Study Results
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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UNKNOWN
PHASE3
128 participants
INTERVENTIONAL
2013-09-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard group
Standard protocol
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
Goal-directed therapy (GDT) protocol
Goal-directed Resuscitation Therapy (GDT)
* A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought.
* The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%.
* When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, 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%.
* If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.
Interventions
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Goal-directed Resuscitation Therapy (GDT)
* A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought.
* The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%.
* When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, 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%.
* If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.
Standard protocol
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years-old
Exclusion Criteria
* Contra-indication for invasive hemodynamic monitoring;
* Expected ICU permanence less than 24 hours;
* Active bleeding
* Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
* Enrolled in other study
* Refuse to consent
18 Years
80 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Ludhmila Abrahão Hajjar
Principal Investigator
Locations
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Intensive Care Unit of the Cancer Institute of Sao Paulo State
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Aline Müller, MD
Role: primary
References
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Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.
Other Identifiers
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GRICS-02
Identifier Type: -
Identifier Source: org_study_id