Clinical trial NCT03138200: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Transfusion; Hemoglobinemia
Hypoxia
Anemia
Keywords: Transfusion
ScvO2
Hemoglobin
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Medical Centre Hungarian Defence Forces
First posted: 2017-05-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Comparison of number of transfuion events in the two groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
city: Budapest
country: Hungary
facility: Department of Anaesthesia and Intensive Care, Medical Centre, Hungarian Defence Force
Study officials:
References:
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.
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.
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.
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.