Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337010
• Other study ID #: CeVOX-study
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 8, 2015
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: January 2015
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Clinical Research Coordination Center Institutional Ethics Review Board for Human Research, University of Szeged: Hungary
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Device:
• CeVOX
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.
• CVP
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.

Drug:
• Fluid 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.
• Vasopressor
If hypotension was present it was treated with vasopressor as 10 mcg bolus or continuous infusion of norepinephrine (Arterenol® Sanofi, Germany).

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (1)

Lead Sponsor	Collaborator
Domonkos Trásy

Country where clinical trial is conducted

Hungary, 

Outcome

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