Clinical trial NCT02104687: Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Abdominal Surgery
Duodenohemipancreatectomy
Rectal Resection
Extensive Bowel Surgery
Keywords: GTD, goal-directed haemodynamic therapy
CI, cardiac index
MAP, mean arterial pressure
CVP, central venous pressure
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pre-defined postoperative complications for up to 28 days after surgery
timeFrame: 24 months
Secondary outcomes:
measure: The length of hospitalization
timeFrame: 24 months
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava
name: Pavel Szturz, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoemaker WC, Appel PL, Kram HB. Hemodynamic and oxygen transport responses in survivors and nonsurvivors of high-risk surgery. Crit Care Med. 1993 Jul;21(7):977-90. doi: 10.1097/00003246-199307000-00010.
citation: Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.