Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

NCT ID: NCT02337010

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CVP

Intervention Type: 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.

Fluid bolus

Intervention Type: 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.

Vasopressor

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

CeVOX

Intervention Type: 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.

Fluid bolus

Intervention Type: 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.

Vasopressor

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Vasopressor

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Domonkos Trásy

OTHER

Sponsor Role: lead

Responsible Party

Domonkos Trásy

Ph.D. student; Department of Anaesthesiology and Intensive Therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, Hungary

Countries

Hungary

References

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.

Reference Type: DERIVED

PMID: 26041437 (View on PubMed)

Other Identifiers

CeVOX-study

Identifier Type: -

Identifier Source: org_study_id