Skip to main content
OpenTrials
Completed

NCT Number: NCT02337010

Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Abdominal Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Fluid Management Perioperative Haemodynamic Monitoring Perioperative Vasopressor Requirement Postoperative Complications Postoperative Organ Function

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Vasopressor

Drug

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

Primary outcomes

  1. Incidence of postoperative complications.

    Time frame: 28 days

Secondary outcomes

  1. Difference in the perioperative fluid requirement

    Time frame: postoperative 48 hours

  2. Difference in the perioperative vasopressor requirement

    Time frame: postoperative 48 hours

Sponsors and collaborators

Lead sponsor

Domonkos Trásy

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2015
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.