Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

NCT02337010 | Completed

• 1 other identifier: CeVOX-study
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative complications.

  28 days

Secondary Outcomes (2)

• Difference in the perioperative fluid requirement

  postoperative 48 hours

• Difference in the perioperative vasopressor requirement

  postoperative 48 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

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; Drug: Fluid bolus; Drug: Vasopressor

CeVOX

EXPERIMENTAL

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; Drug: Fluid bolus; Drug: Vasopressor

Interventions

CeVOX DEVICE

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.

CeVOX

CVP DEVICE

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.

Control

Fluid bolus DRUG

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.

CeVOX; Control

Vasopressor DRUG

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

CeVOX; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Domonkos Trásy: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

Location

Related Publications (1)

• 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.

  PMID: 26041437 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. student; Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 13, 2015
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

HU (1)