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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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Purpose
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 | Intervention |
|---|---|
| Blood Transfusion; Hemoglobinemia Hypoxia Anemia | Biological: Blood transfusion |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Supportive Care |
| Official Title: | The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill |
- 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.
| Estimated Enrollment: | 160 |
| Actual Study Start Date: | March 8, 2017 |
| Estimated Study Completion Date: | March 1, 2019 |
| Estimated Primary Completion Date: | March 1, 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT03138200
| 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 | |
More Information
Publications:
| Responsible Party: | Zsolt Molnár, MD, PhD, DEAA, Principal Investigator, Szeged University |
| ClinicalTrials.gov Identifier: | NCT03138200 History of Changes |
| Other Study ID Numbers: |
ScvO2 transfusion |
| Study First Received: | March 8, 2017 |
| Last Updated: | April 28, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on July 14, 2017