Postoperative Complications Clinical Trial
Official title:
Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management During Major Abdominal Surgery
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Hungary | Department of Anaesthesiology and Intensive Therapy | Szeged | Csongrád |
Lead Sponsor | Collaborator |
---|---|
Domonkos Trásy |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of postoperative complications. | 28 days | No | |
Secondary | Difference in the perioperative fluid requirement | postoperative 48 hours | No | |
Secondary | Difference in the perioperative vasopressor requirement | postoperative 48 hours | No |
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