Oxygen Consumption Clinical Trial
Official title:
Assessment of Oxygen Extraction Rate Changes Following Red Blood Cell Transfusion in the Intensive Care Unit: a Prospective Observational Non-interventional Study
Verified date | November 2023 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Restrictive and liberal approaches to hemoglobin targets are used when deciding on red blood cell transfusions in patients who do not have acute bleeding and have a hemodynamically stable course in the intensive care unit. However, physiologic trigger points that assess tissue oxygenation when deciding on blood transfusion in patients are also among the important topics of study in recent years. In this study, the investigators will evaluate the oxygen extraction rate, which is an important indicator of the balance between tissue oxygen delivery and consumption. Whether oxygen extraction rate can be used as a trigger for blood transfusion will be determined by clinical outcomes in ICU patients. If physiologic transfusion targets are feasible, the risks of unnecessary transfusions can be avoided with individualized targets, and the decision to transfuse blood can be made without delay in patients requiring red blood cell transfusion.
Status | Completed |
Enrollment | 88 |
Est. completion date | December 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years old - Patients followed in the intensive care unit for at least 24 hours - Patients with central venous catheters - Patients who have received a decision to transfuse red blood cells Exclusion Criteria: - Patients with hemodynamically unstable - Patients with acute bleeding - Patients in hemorrhagic shock - Patients with acute traumatic brain injury - Pregnant patients |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Anesthesiology and Reanimation | Izmir |
Lead Sponsor | Collaborator |
---|---|
Izmir Katip Celebi University |
Turkey,
Orlov D, O'Farrell R, McCluskey SA, Carroll J, Poonawala H, Hozhabri S, Karkouti K. The clinical utility of an index of global oxygenation for guiding red blood cell transfusion in cardiac surgery. Transfusion. 2009 Apr;49(4):682-8. doi: 10.1111/j.1537-2995.2008.02022.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage change in oxygen extraction rate | Evaluate the percentage change in oxygen extraction rate after and before red blood cell transfusion between the two groups with oxygen extraction rates of > 30% and =30%. | After transfusion of 15.minutes | |
Secondary | 7, 28 and 90 days mortality | 7, 28 and 90 days mortality | 7, 28 and 90 days | |
Secondary | Near infrared spectroscopy values change | Near infrared spectroscopy values change | After transfusion of 15.minutes | |
Secondary | Length of ICU stay | Length of ICU stay | up to 90 days | |
Secondary | Complication rates | Complication rates | up to 90 days | |
Secondary | Length of hospital stay | Length of hospital stay | up to 90 days | |
Secondary | Number of mechanical ventilation dependent days | Number of mechanical ventilation dependent days | up to 90 days |
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