The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
* 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.
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
Intensive Care Unit of the Cancer Institute of Sao Paulo State
São Paulo, São Paulo, Brazil
RECRUITINGComposite endpoint 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.
Time frame: 30 days after randomization
Duration of ICU stay and hospital stay
To compare the number of days of ICU stay and hospital stay between groups.
Time frame: 30 days after randomization
Tissue hypoperfusion markers
To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.
Time frame: 7 days after randomization
Daily SOFA score
Daily sequential organ failure assessment score within the first 7 days after randomization
Time frame: 7 days after randomization
Cardiovascular complications
To compare the incidence of cardiovascular complications between groups. Cardiovascular complications will be defined as myocardial ischemia, acute decompensated heart failure, mesenteric ischemia, pulmonary thromboembolism and peripheral vascular ischemia.
Time frame: 30 days after randomization
Respiratory complications
Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria
Time frame: 30 days after randomization
Severe Renal complication
Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.
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Time frame: 30 days after randomization
Neurological complications
To compare the incidence of stroke between groups within 30 days after randomization.
Time frame: 30 days after randomization
Severe infectious complications
To compare the incidence, between groups, of infectious complications defined as a new septic shock.
Time frame: 30 days after randomization
Surgical complications
To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death
Time frame: 30 days after randomization