Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Sponsor

Domonkos Trásy (Other)

Overall Status

Completed

CT.gov ID

NCT02337010

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Abdominal Surgery Perioperative Haemodynamic Monitoring Perioperative Fluid Management Perioperative Vasopressor Requirement Postoperative Organ Function Postoperative Complications	Device: CeVOX Device: CVP Drug: Fluid bolus Drug: Vasopressor	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

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.	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. 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).

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.

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.

Drug: Fluid bolus

Drug: Vasopressor

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

Outcome Measures

Primary Outcome Measures

Incidence of postoperative complications. [28 days]

Secondary Outcome Measures

Difference in the perioperative fluid requirement [postoperative 48 hours]
Difference in the perioperative vasopressor requirement [postoperative 48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád	Hungary	H-6725

Sponsors and Collaborators

Domonkos Trásy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Domonkos Trásy, Ph.D. student; Department of Anaesthesiology and Intensive Therapy, Szeged University

ClinicalTrials.gov Identifier:

NCT02337010

Other Study ID Numbers:

CeVOX-study

First Posted:

Jan 13, 2015

Last Update Posted:

Jan 13, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Postoperative Complications

Vasoconstrictor Agents

Study Results

No Results Posted as of Jan 13, 2015