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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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ClinicalTrials.gov Identifier: NCT03138200
Recruitment Status : Unknown
Verified April 2017 by Zsolt Molnár, MD, PhD, DEAA, Szeged University.
Recruitment status was:  Recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Medical Centre Hungarian Defence Forces
Information provided by (Responsible Party):
Zsolt Molnár, MD, PhD, DEAA, Szeged University

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.


Condition or disease Intervention/treatment Phase
Blood Transfusion; Hemoglobinemia Hypoxia Anemia Biological: Blood transfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Blood transfusion based on central venous oxygen saturation Biological: Blood transfusion
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 Measures :
  1. Comparison of number of transfuion events in the two groups [ Time Frame: 2 years ]
    Comparison of how many tranfusions were performed based on ScvO2 to conventional, hemoglobin based transfusion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138200


Locations
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Hungary
Department of Anaesthesiology and Intensive Therapy Recruiting
Szeged, Csongrád, Hungary, 6725
Contact: Petra Dalmann    +36 62 - 545 168    office.aiti@med.u-szeged.hu   
Department of Anaesthesia and Intensive Care, Medical Centre, Hungarian Defence Force Active, not recruiting
Budapest, Hungary, 1134
Sponsors and Collaborators
Szeged University
Medical Centre Hungarian Defence Forces

Publications:
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Responsible Party: Zsolt Molnár, MD, PhD, DEAA, Principal Investigator, Szeged University
ClinicalTrials.gov Identifier: NCT03138200     History of Changes
Other Study ID Numbers: ScvO2 transfusion
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zsolt Molnár, MD, PhD, DEAA, Szeged University:
Transfusion
ScvO2
Hemoglobin
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms