An interventional study of CeVOX and CVP in Major Abdominal Surgery, Perioperative Haemodynamic Monitoring and Perioperative Fluid Management, sponsored by Domonkos Trásy. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-13.
Sponsored by Domonkos Trásy · Not applicable and Interventional
Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy, pancreas resection, major vascular, total cystectomy will be recruited.To investigate effects of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid management on intraoperative haemodynamic parameters, volume and vasopressor requirement, and postoperative organ function and postoperative inflammatory response.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 79 is below the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Domonkos Trásy is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the control group if the mean arterial pressure fall below 60 mm Hg and the central venous pressure (CVP) is low fluid bolus is administered if the central venous pressure is in normal range vasopressor is given.
Device: CVP · Drug: Fluid bolus · Drug: Vasopressor
In the ScvO2 group patients receive interventions in two options: if the ScvO2 fall below 75% or more than 3% or if the mean arterial pressure fall below 60 mm Hg. In the former case the mean arterial pressure in the latter the ScvO2 values determined if tha patient received fluid or vasopressor or both.
Device: CeVOX · Drug: Fluid bolus · Drug: Vasopressor
Central venous saturation was continuously monitored by using a CeVOX monitor (Pulsion Medical Systems, Munich, Germany). The CeVOX probe (PV2022-37; Pulsion Medical Systems, Munich, Germany) was inserted into the internal jugular central venous catheter as described in the user's manual.
Central venous pressure was continuously monitored by using a central venous catheter. The probe was inserted into the internal jugular central vein as described in the user's manual.
If hypovolaemia was suspected fluid bolus was given in the form of 250 ml hydroxyethyl starch solution (HES, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride, Voluven, Fresenius Kabi, Germany) over 15 minutes.
If hypotension was present it was treated with vasopressor as 10 mcg bolus or continuous infusion of norepinephrine (Arterenol® Sanofi, Germany).
Incidence of postoperative complications.
Time frame: 28 days
Difference in the perioperative fluid requirement
Time frame: postoperative 48 hours
Difference in the perioperative vasopressor requirement
Time frame: postoperative 48 hours
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Domonkos Trásy