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

NCT03138200 | Unknown

• 1 other identifier: ScvO2 transfusion
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Blood Transfusion; Hemoglobinemia; Hypoxia; Anemia

Keywords

Transfusion; ScvO2; Hemoglobin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Blood transfusion based on central venous oxygen saturation

OTHER

Biological: Blood transfusion

Interventions

Blood transfusion BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• Head injury requiring ICP monitoring guided control of ICP
• Shock of any origin
• Patients with heart failure
• Patients with renal failure

Sponsors & Collaborators

• Szeged University: lead
• Medical Centre Hungarian Defence Forces: collaborator

Study Sites (2)

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6725, Hungary

RECRUITING

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

Budapest, 1134, Hungary

ACTIVE NOT RECRUITING

Related Publications (4)

• 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.

  PMID: 20440603 BACKGROUND

• 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.

  PMID: 20236457 BACKGROUND

• 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.

  PMID: 19467825 BACKGROUND

• 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.

  PMID: 22260228 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Anemia

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: May 3, 2017
• Study Start: March 8, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 3, 2017

Record last verified: 2017-04

Locations

HU (2)