NCT02104687

Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Abdominal Surgery
• Duodenohemipancreatectomy
• Rectal Resection
• Extensive Bowel Surgery

Interventions

Type	Name	Description
PROCEDURE	Flow group	After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.
PROCEDURE	Press group	After induction, the parameters of MAP and CVP will be monitored in each of the patients.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2014-04-04
• Last updated: 2016-09-08

Locations

1 site across 1 country: Czechia