Postoperative Care
Conditions
Brief summary
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.
Interventions
* 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.
OTHERStandard protocol
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment * Age over 18 years-old
Exclusion criteria
* Weight under 55 kilograms or over 140 kilograms; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of death or major postoperative complications | 30 days after randomization | Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Renal complication | 30 days after randomization | Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3. |
| Cardiovascular complications | 30 days after randomization | 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. |
| Duration of ICU stay and hospital stay | 30 days after randomization | To compare the number of days of ICU stay and hospital stay between groups. |
| Tissue hypoperfusion markers | 7 days after randomization | To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups. |
| Respiratory complications | 30 days after randomization | Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria |
| Neurological complications | 30 days after randomization | To compare the incidence of stroke between groups within 30 days after randomization. |
| Severe infectious complications | 30 days after randomization | To compare the incidence, between groups, of infectious complications defined as a new septic shock. |
| Surgical complications | 30 days after randomization | To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death |
| Daily SOFA score | 7 days after randomization | Daily sequential organ failure assessment score within the first 7 days after randomization |
Countries
Brazil
Contacts
Primary ContactAline Müller, MD
Outcome results
None listed