Skip to main content
OpenTrials
Completed

NCT Number: NCT02104687

Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, 70852, Czechia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flow group

Procedure

After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.

Press group

Procedure

After induction, the parameters of MAP and CVP will be monitored in each of the patients.

Primary outcomes

  1. Pre-defined postoperative complications for up to 28 days after surgery

    Time frame: 24 months

    The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

Secondary outcomes

  1. The length of hospitalization

    Time frame: 24 months

    Length of hospital stay will be obtained from the patient record.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study 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

Acronym: Flow-press

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2014
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.