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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03138200
• Other study ID #: ScvO2 transfusion
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2017
• Last updated: April 28, 2017
• Start date: March 8, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2017
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Blood Transfusion; Hemoglobinemia
• Critical Illness
• Hypoxia

Intervention

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.

Locations

Country	Name	City	State
Hungary	Department of Anaesthesia and Intensive Care, Medical Centre, Hungarian Defence Force	Budapest
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (2)

Lead Sponsor	Collaborator
Szeged University	Medical Centre Hungarian Defence Forces

Country where clinical trial is conducted

Hungary, 

References & Publications (4)

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. — View Citation

Blood Observational Study Investigators of ANZICS-Clinical Trials Group., Westbrook A, Pettilä 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. — View Citation

Kocsi S, Demeter G, Fogas J, Erces D, Kaszaki J, Molnár 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years