Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters (Flow-press)

September 7, 2016 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flow
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
After induction, the parameters of MAP and CVP will be monitored in each of the patients.
Active Comparator: Press
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
After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.

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
Time Frame: 24 months
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
Time Frame: 24 months
Length of hospital stay will be obtained from the patient record.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Pavel Szturz, MD, Ph.D., University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FNO-KARIM-1
  • SGS05/LF/2014 (Other Grant/Funding Number: Medical Faculty, Ostrava University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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