Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Major Abdominal Surgery; Perioperative Fluid Management; Perioperative Haemodynamic Monitoring; Perioperative Vasopressor Requirement; Postoperative Organ Function
• Intervention / Treatment: Device: CVP; Drug: Fluid bolus; Drug: Vasopressor; Device: CeVOX

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, H-6725
      • Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative complications.	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Domonkos Trásy

Publications and helpful links

General Publications

• Mikor A, Trasy D, Nemeth MF, Osztroluczki A, Kocsi S, Kovacs I, Demeter G, Molnar Z. Continuous central venous oxygen saturation assisted intraoperative hemodynamic management during major abdominal surgery: a randomized, controlled trial. BMC Anesthesiol. 2015 Jun 4;15:82. doi: 10.1186/s12871-015-0064-2.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Vasoconstrictor Agents
• Other Study ID Numbers: CeVOX-study