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
|Condition or disease||Intervention/treatment||Phase|
|Major Abdominal Surgery Duodenohemipancreatectomy Rectal Resection Extensive Bowel Surgery||Procedure: Flow group Procedure: Press group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- The length of hospitalization [ Time Frame: 24 months ]Length of hospital stay will be obtained from the patient record.
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
|University Hospital Ostrava|
|Ostrava, Czech Republic, 70852|
|Principal Investigator:||Pavel Szturz, MD, Ph.D.||University Hospital Ostrava|