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

U

University Hospital Ostrava

Status

Completed

Conditions

Major Abdominal Surgery
Extensive Bowel Surgery
Rectal Resection
Duodenohemipancreatectomy

Treatments

Procedure: Press group
Procedure: Flow group

Study type

Interventional

Funder types

Other

Identifiers

NCT02104687
SGS05/LF/2014 (Other Grant/Funding Number)
FNO-KARIM-1

Details and patient eligibility

About

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.

Full 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).

Enrollment

140 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

Flow
Active Comparator group
Description:
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.
Treatment:
Procedure: Press group
Press
Active Comparator group
Description:
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.
Treatment:
Procedure: Flow group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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