Goal-Directed Therapy in Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study

Conditions
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Postoperative Care

Intervention / Treatment
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* Other: Goal-directed Resuscitation Therapy (GDT)
* Other: Standard protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard group<br> | Other: Standard protocol<br>* The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.<br>|
| Active Comparator: Goal-directed therapy (GDT) protocol<br> | Other: Goal-directed Resuscitation Therapy (GDT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite 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. | 30 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ICU stay and hospital stay | To compare the number of days of ICU stay and hospital stay between groups. | 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. | 7 days after randomization | 
| Daily SOFA score | Daily sequential organ failure assessment score within the first 7 days after randomization | 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. | 30 days after randomization | 
| Respiratory complications | Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria | 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. | 30 days after randomization | 
| Neurological complications | To compare the incidence of stroke between groups within 30 days after randomization. | 30 days after randomization | 
| Severe infectious complications | To compare the incidence, between groups, of infectious complications defined as a new septic shock. | 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 | 30 days after randomization |