Major Abdominal Surgery, Perioperative Haemodynamic Monitoring, Perioperative Fluid Management, Perioperative Vasopressor Requirement, Postoperative Organ Function, Postoperative Complications
Conditions
Brief summary
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.
Interventions
DEVICECeVOX
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.
DEVICECVP
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.
DRUGFluid bolus
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.
DRUGVasopressor
If hypotension was present it was treated with vasopressor as 10 mcg bolus or continuous infusion of norepinephrine (Arterenol® Sanofi, Germany).
Sponsors
Domonkos Trásy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing the following elective major abdominal surgery: oesophagectomy, total gastrectomy, radical cystectomy, aorta-bifemoral bypass or elective operation of abdominal aortic aneurysm. * after surgery patients were admitted to our intensive care unit.
Exclusion criteria
* patients younger than 18 years * chronic organ insufficiency: Acute Physiology and Chronic Health Evaluation (APACHE) II scoring system: New York Heart Association Class IV, chronic hypoxia or hypercapnia, chronic renal failure requiring renal replacement therapy, biopsy proven cirrhosis or portal hypertension and immunodeficiency. * preoperative anaemia (haemoglobin\<100g/L) * coagulation abnormality * and patients with chronic use of corticosteroids and non-steroid anti-inflammatory drugs * patients requiring an operation due to malignant disease where the tumour then proved to be inoperable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative complications. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the perioperative fluid requirement | postoperative 48 hours |
| Difference in the perioperative vasopressor requirement | postoperative 48 hours |
Countries
Hungary
Outcome results
None listed