Trial | NCT03138200  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    160
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.
Study Started
Mar 08
2017
Primary Completion
Mar 01
2019
Anticipated
Study Completion
Mar 01
2019
Anticipated
Last Update
May 03
2017

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.

Blood transfusion based on central venous oxygen saturation Other

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
No Results Posted