Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Not Applicable

Completed

• Conditions: Postoperative Organ Function; Perioperative Vasopressor Requirement; Major Abdominal Surgery; Perioperative Haemodynamic Monitoring; Postoperative Complications; Perioperative Fluid Management
• Interventions: Device: CVP; Device: CeVOX; Drug: Fluid bolus; Drug: Vasopressor

• Registration Number: NCT02337010
• Lead Sponsor: Domonkos Trásy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-01
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-08
• Last Update Submitted: 2015-01-08
• Study First Posted: 2015-01-13
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CeVOX	Fluid bolus	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.
Control	CVP	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.
Control	Fluid bolus	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.
Control	Vasopressor	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.
CeVOX	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.
CeVOX	Vasopressor	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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative complications.	28 days

Secondary Outcome Measures

Name	Time	Method
Difference in the perioperative fluid requirement	postoperative 48 hours
Difference in the perioperative vasopressor requirement	postoperative 48 hours

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Szeged, Csongrád, Hungary