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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02337010
Other study ID # CeVOX-study
Secondary ID
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


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
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