Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management During Major Abdominal Surgery

Conditions
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Perioperative Haemodynamic Monitoring, Major Abdominal Surgery, Perioperative Fluid Management, Perioperative Vasopressor Requirement, Postoperative Organ Function, Postoperative Complications

Intervention / Treatment
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* Device: CeVOX
* Device: CVP
* Drug: Fluid bolus
* Drug: Vasopressor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* 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.<br>Drug: Fluid bolus<br>* 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.<br>Drug: Vasopressor<br>* If hypotension was present it was treated with vasopressor as 10 mcg bolus or continuous infusion of norepinephrine (Arterenol® Sanofi, Germany).<br>|
| Experimental: CeVOX<br>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<br>* 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.<br>Drug: Fluid bolus<br>* 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.<br>Drug: Vasopressor<br>* If hypotension was present it was treated with vasopressor as 10 mcg bolus or continuous infusion of norepinephrine (Arterenol® Sanofi, Germany).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative complications. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the perioperative fluid requirement |  | postoperative 48 hours | 
| Difference in the perioperative vasopressor requirement |  | postoperative 48 hours |