Perioperative Hemodynamic Optimization Using the NICOM Device

Study Overview
=================
Brief Summary
-----------------
In the last years, there is a growing interest in the improvement of prognosis and shortening of hospital length of stay in high-risk surgical patients. Several evidence-based protocols (fast-track surgery) have been developed and implemented in some hospitals for this purpose. Cardiovascular optimization through the so-called goal-directed therapy (GDT) is a key element in these protocols. Previous studies in the literature use invasive monitors to assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical scenarios. The aim of the present randomized, international, multi-center, open-label clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial pressure) to test the hypothesis that GDT is superior to standard practice in terms of reduction in the incidence of perioperative complications and length of hospital stay in high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24 hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and mortality will be analysed. All patients will be followed from the day of surgery up to hospital discharge (determined by a specialist surgeon not involved in the study) or death.

Official Title
-----------------
Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery

Conditions
-----------------
Major Abdominal Surgery

Intervention / Treatment
-----------------
* Device: Hemodynamic monitoring
* Other: Usual treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients scheduled for: Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection. Gastrectomy. Small bowel resection. Signed written informed consent. Exclusion Criteria: Less than 18 years old. Laparoscopic procedure. Emergency surgery. Intra-abdominal infection. Patients not requiring ICU admission (patients should stay for at least the first day at the ICU). Life expectancy lower than 60 days. Disseminated malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Usual treatment<br>The hemodynamic management will be performed according to the institution's standard of care, using fluids at the discretion of the anesthesiologist and the ICU specialist. | Other: Usual treatment<br>* Hemodynamic monitoring based on common practice<br>|
| Active Comparator: NICOM<br>For volume replacement, crystalloids will be used following the standard procedure according to the anesthesiologist or ICU specialist. Mean arterial pressure and cardiac index will be assessed every 5 minutes, and a volume bolus (250 mL colloid in 10 minutes) will be used to achieve a: Mean arterial pressure ≥ 65 mmHg (intra and postoperatively), AND Cardiac index ≥ 2.5 L/min/m2 (intra and postoperatively). If these cardiovascular parameters are not met after the first colloid infusion, a supplementary bolus will be added. In case of not achieving the target, additional colloid boluses and/or pharmacologic support (norepinephrine in case of persistent hypotension, dobutamine in case of low cardiac output) will be provided according to the protocol | Device: Hemodynamic monitoring<br>* Hemodynamic monitoring based on the NICOM device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in hospital length of stay |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to peristalsis recovery | Peristalsis shall be assessed by first flatus after abdominal surgery | Three weeks | 
| Incidence of wound infection |  | Three weeks | 
| Incidence of anastomotic leaks |  | Three weeks | 
| Any cause mortality |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodynamic Monitoring, Goal-Directed Therapy