An interventional study of Flow group and Press group in Major Abdominal Surgery, Duodenohemipancreatectomy and Rectal Resection, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-09-08.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
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.
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).
University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
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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
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.
After induction, the parameters of MAP and CVP will be monitored in each of the patients.
Pre-defined postoperative complications for up to 28 days after surgery
The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.
Time frame: 24 months
The length of hospitalization
Length of hospital stay will be obtained from the patient record.
Time frame: 24 months
The record gives a start of Apr 2014, a primary completion of Jun 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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