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The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill

Primary Purpose

Blood Transfusion; Hemoglobinemia, Hypoxia, Anemia

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Blood transfusion
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Transfusion; Hemoglobinemia focused on measuring Transfusion, ScvO2, Hemoglobin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult (>18 y)
  2. Critically ill anemic but hemodynamically stable patients treated on the ICU in whom transfusion is considered by the attending physician
  3. Routine ICU monitoring: invasive blood pressure, CVC, hourly urine output
  4. Anemia is defined as Hb<100 g/L
  5. Hemodynamic stability is defined as:

    1. heart rate (HR)<100/min,
    2. mean arterial pressure (MAP)>60 mmHg
    3. no or "minimal" requirement of noradrenaline (NA): compensation for sedation not exceeding 5 µg/min
    4. stable homeostasis:

    i. pH: 7.30-7.45 ii. HCO3 > 20 mmol/L iii. lactate < 2 mmol/L e. normal hourly urine output for the last 2 hours not facilitated by diuretics: >0.5ml/kg/h

  6. Central venous catheter in situ (position in the v. cava superior confirmed by chest x-ray)

Exclusion Criteria:

  1. Pregnancy
  2. Head injury requiring ICP monitoring guided control of ICP
  3. Shock of any origin
  4. Patients with heart failure
  5. Patients with renal failure

Sites / Locations

  • Department of Anaesthesiology and Intensive TherapyRecruiting
  • Department of Anaesthesia and Intensive Care, Medical Centre, Hungarian Defence Force

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood transfusion based on central venous oxygen saturation

Arm Description

Outcomes

Primary Outcome Measures

Comparison of number of transfuion events in the two groups
Comparison of how many tranfusions were performed based on ScvO2 to conventional, hemoglobin based transfusion.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2017
Last Updated
April 28, 2017
Sponsor
Szeged University
Collaborators
Medical Centre Hungarian Defence Forces
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1. Study Identification

Unique Protocol Identification Number
NCT03138200
Brief Title
The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill
Official Title
The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University
Collaborators
Medical Centre Hungarian Defence Forces

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transfusion of red blood cells is an everyday practice in critical care with the primary aim of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and costly, therefore a so called restrictive transfusion regime has been suggested by recent guidelines. These transfusion guidelines consider certain levels of hemoglobin as transfusion trigger, which on its own gives little information if any about the balance between oxygen delivery (DO2) and consumption (VO2). Hence, there is a clear need for additional physiologic transfusion trigger values. One of the potentially useful and easily obtainable physiological parameters is the central venous oxygen saturation (ScvO2), which has been shown to be a potential transfusion trigger value in hemodynamically stable but anemic patients. However, the role of ScvO2 as a transfusion trigger value was examined only in a retrospective observational study and in animal experiment. The normal value of ScvO2 in a resting adult at rest is around 70-75%, which is the product of the VO2 and DO2 relationship. Low ScvO2 usually indicates inadequate DO2. It was found in an observational study that if ScvO2>70% before transfusion due to transfusion only the value of hemoglobin increased but the value of ScvO2 did not change. This finding indicates that the DO2 may have been adequate in spite of the low hemoglobin value and the transfusion may have been unnecessary. In one of their recent animal experiments, the investigators reported that in an isovolemic-anemia model the value of ScvO2<70% was only reached when the value of hemoglobin was far less, 59 g/L, than the recommended lowest value of 70g/L as transfusion trigger by guidelines. Despite the pathophysiological rationale and the encouraging results of retrospective studies and animal experiments, prospective randomized trials in order to test the effects of an ScvO2-assisted transfusion protocol are yet to be performed. The aim of this study is to investigate the effects of an ScvO2-assisted transfusion protocol as compared to the guideline-based, hemoglobin levels guided transfusion practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Transfusion; Hemoglobinemia, Hypoxia, Anemia
Keywords
Transfusion, ScvO2, Hemoglobin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood transfusion based on central venous oxygen saturation
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Blood transfusion
Intervention Description
Blood transfusion is a safe, routine procedure in which blood is given to a patient through an intravenous cannula inserted into one of the patient's veins.
Primary Outcome Measure Information:
Title
Comparison of number of transfuion events in the two groups
Description
Comparison of how many tranfusions were performed based on ScvO2 to conventional, hemoglobin based transfusion.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (>18 y) Critically ill anemic but hemodynamically stable patients treated on the ICU in whom transfusion is considered by the attending physician Routine ICU monitoring: invasive blood pressure, CVC, hourly urine output Anemia is defined as Hb<100 g/L Hemodynamic stability is defined as: heart rate (HR)<100/min, mean arterial pressure (MAP)>60 mmHg no or "minimal" requirement of noradrenaline (NA): compensation for sedation not exceeding 5 µg/min stable homeostasis: i. pH: 7.30-7.45 ii. HCO3 > 20 mmol/L iii. lactate < 2 mmol/L e. normal hourly urine output for the last 2 hours not facilitated by diuretics: >0.5ml/kg/h Central venous catheter in situ (position in the v. cava superior confirmed by chest x-ray) Exclusion Criteria: Pregnancy Head injury requiring ICP monitoring guided control of ICP Shock of any origin Patients with heart failure Patients with renal failure
Facility Information:
Facility Name
Department of Anaesthesiology and Intensive Therapy
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Dalmann
Phone
+36 62 - 545 168
Email
office.aiti@med.u-szeged.hu
Facility Name
Department of Anaesthesia and Intensive Care, Medical Centre, Hungarian Defence Force
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20440603
Citation
Blood Observational Study Investigators of ANZICS-Clinical Trials Group; Westbrook A, Pettila V, Nichol A, Bailey MJ, Syres G, Murray L, Bellomo R, Wood E, Phillips LE, Street A, French C, Orford N, Santamaria J, Cooper DJ. Transfusion practice and guidelines in Australian and New Zealand intensive care units. Intensive Care Med. 2010 Jul;36(7):1138-46. doi: 10.1007/s00134-010-1867-8. Epub 2010 May 4.
Results Reference
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PubMed Identifier
20236457
Citation
Vallet B, Robin E, Lebuffe G. Venous oxygen saturation as a physiologic transfusion trigger. Crit Care. 2010;14(2):213. doi: 10.1186/cc8854. Epub 2010 Mar 9.
Results Reference
background
PubMed Identifier
19467825
Citation
Adamczyk S, Robin E, Barreau O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. [Contribution of central venous oxygen saturation in postoperative blood transfusion decision]. Ann Fr Anesth Reanim. 2009 Jun;28(6):522-30. doi: 10.1016/j.annfar.2009.03.013. Epub 2009 May 20. French.
Results Reference
background
PubMed Identifier
22260228
Citation
Kocsi S, Demeter G, Fogas J, Erces D, Kaszaki J, Molnar Z. Central venous oxygen saturation is a good indicator of altered oxygen balance in isovolemic anemia. Acta Anaesthesiol Scand. 2012 Mar;56(3):291-7. doi: 10.1111/j.1399-6576.2011.02622.x. Epub 2012 Jan 19.
Results Reference
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The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill

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