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

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ClinicalTrials.gov Identifier: NCT02104687
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Duodenohemipancreatectomy Rectal Resection Extensive Bowel Surgery Procedure: Flow group Procedure: Press group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. The length of hospitalization [ Time Frame: 24 months ]
    Length of hospital stay will be obtained from the patient record.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104687


Locations
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Czech Republic
University Hospital Ostrava
Ostrava, Czech Republic, 70852
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Pavel Szturz, MD, Ph.D. University Hospital Ostrava

Publications:
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02104687     History of Changes
Other Study ID Numbers: FNO-KARIM-1
SGS05/LF/2014 ( Other Grant/Funding Number: Medical Faculty, Ostrava University )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Keywords provided by University Hospital Ostrava:
GTD, goal-directed haemodynamic therapy
CI, cardiac index
MAP, mean arterial pressure
CVP, central venous pressure