Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on cardiac index trending by transesophageal Dopplerometry would result in reduced complications and reduced length of hospital stay in major abdominal surgery patients, when compared to patients treated with press treatment algorithm.

Detailed Description
-----------------
Despite standardisation of intraoperative care provided for risk surgery patients, the preoperative mortality remains higher than expected. The aim of the goal-directed heamodynamic therapy (GDT) is to improve the altered cardiovascular function and to reach the desired intraoperative values of oxygen supply (DO2) and cardiac index (CI). Standard haemodynamic measurements, such as heart rate (HR), mean arterial pressure (MAP) and central venous pressure (CVP) remain relatively unchanged despite reduced blood flow. However, GTD is able to detect early hypo perfusion abnormalities. The aim of goal-directed heamodynamic therapy, based on the titration of fluids and vasoactive drugs to physiological flow-related end points is to reduce perioperative complications, perioperative morbidity and mortality. We hypothesise, that following this treatment regimen results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secondary endpoint).

Official Title
-----------------
The Influence of Intraoperative Goal-directed Hemodynamic Therapy Based on Cardiac Index Trending on the Volume of Intraoperatively Administered Fluids and Vasoactive Agents in Comparison to Standard Pressure Monitoring in Patients Undergoing Major Elective Abdominal Surgery

Conditions
-----------------
Major Abdominal Surgery, Duodenohemipancreatectomy, Rectal Resection, Extensive Bowel Surgery

Intervention / Treatment
-----------------
* Procedure: Flow group
* Procedure: Press group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21 years of age and above anticipated duration of surgery more than 120 minutes estimated blood loss exceeding more than 15% of blood volume American Society of Anesthesiology (ASA) classification 2 or 3 indication for an arterial line and central venous catheter Exclusion Criteria: pregnant or lactating women age below 21 years of age emergency surgery American Society of Anesthesiology (ASA) classification 1 sepsis and septic shock severe cardiac arrhythmias patients with pathology or intervention on oesophagus

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flow<br>The Flow therapeutic algorithm will be responsible for adjustment of intraoperative interventions - volumotherapy and administration of vasoactive drugs, with the aim to maintain the CI value >2.5 l/m/m2 (FTc - flow time <330 ms was chosen as variable defining preload; PV, peak velocity <70 ms-1 will be used as a variable defining contractility; SVR, total systemic vascular resistance between 1000-1800 cdyn.s/cm5m2 will be used as variable defining after load). After the desired values of CI have been obtained, no further increase of therapeutic intervention (fluids, vasoactive drugs) will be performed. | Procedure: Press group<br>* After induction, the parameters of MAP and CVP will be monitored in each of the patients.<br>|
| Active Comparator: Press<br>The Press therapeutic algorithm will be responsible for adjustment of intraoperative interventions based upon standard pressure parameters and will include volumotherapy and administration of vasoactive drugs, with the aim to maintain the desired values of MAP of 65-105 mmHg and CVP 8-12 mmHg. After the desired values of MAP and CVP have been obtained, no further increase of therapeutic intervention (fluids, vasoactive drugs) will be performed. | Procedure: Flow group<br>* After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-defined postoperative complications for up to 28 days after surgery | The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of hospitalization | Length of hospital stay will be obtained from the patient record. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GTD, goal-directed haemodynamic therapy, CI, cardiac index, MAP, mean arterial pressure, CVP, central venous pressure