Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Domonkos Trásy

Status: Completed

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

Treatments: Drug: Fluid bolus; Device: CeVOX; Device: CVP; Drug: Vasopressor

Study type: Interventional

Funder types: Other

Identifiers

NCT02337010

CeVOX-study

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

79 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Vasopressor

Device: CVP

Drug: Fluid bolus

CeVOX

Experimental group

Description:

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.

Treatment:

Device: CeVOX

Drug: Vasopressor

Drug: Fluid bolus