Uppsala University Hospital
Uppsala, Sweden
Location status: Recruiting
NCT Number: NCT06930443
The goal of this observational study is to understand how oxygen consumption after heart surgery relates to blood flow problems and organ injury. The study focuses on patients over 18 years old who are having planned heart surgery with a heart-lung machine (cardiopulmonary bypass).
The main questions the study aims to answer are:
1. How does oxygen consumption in the early hours after surgery relate to lactate levels (a sign of low oxygen supply to the tissues)? 2. How is oxygen consumption linked to signs of poor blood flow and organ injury (such as heart, kidney, liver, brain, and gut damage)?
Researchers will measure oxygen consumption after surgery using a technique called indirect calorimetry. They will also track blood flow and oxygen use during surgery and check for signs of organ injury the day after the procedure. The study will include 65 participants. People with certain health conditions, like severe anemia, high lactate levels before surgery, or needing intensive care or extra oxygen supply before surgery, will not be included. By understanding how oxygen consumption relates to blood flow and organ injury, this research may help to better manage patients after heart surgery and reduce complications.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Uppsala, Sweden
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After arrival to the ICU, prior to cessation of iv anaesthetics and extubation, indirect calorimetry will be performed by connecting a metabolic monitor to the ventilator during a minimum of 20 minutes.
Time frame: 0-4 hours after surgery
Difference in oxygen consumption (VO2I via indirect calorimetry) in ml min-1 m-2 between patients with and without early hyperlactatemia (>2mmol/L)
Time frame: 0-24 hours after surgery
Hypoperfusion parameters will be evaluated as a predictors of postoperative oxygen consumption (VO2I, ml min-1 m-2 via indirect calorimetry).
Blood gas parameters taken preoperatively and at spaced time-points up to 24 hrs after start of surgery:
Clinical variables measured hourly or otherwise specified:
Additional explorative data analyses for hypothesis generating purposes can be performed.
Time frame: 0-4 hours during and after surgery
Oxygen delivery (DO2I, ml min-1 m-2) and oxygen consumption (VO2I ml min-1 m-2) will be measured during cardiopulmonary bypass by continuous blood parameter monitoring or calculated by blood oxygen content and pump flow. Both mean levels and repeated measures will be analysed as predictors for postoperative oxygen consumption. Additional explorative data analyses for hypothesis generating purposes can be performed.
Time frame: Preoperative and the day after surgery
Organ injury markers will be evaluated as predictors for postoperative oxygen consumption. Absolute levels, changes from preoperative values, and above normal predicted value (yes/no) will be used in the analysis.
Blood sampling preoperatively and the day after surgery.
Contact information is provided by the study sponsor or research team.
Julia Jakobsson MD PhD
CONTACT
Olle Lönnemark MD
CONTACT
Uppsala University Hospital
Other
Oxygen Consumption, Early Postoperative Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass: a Prospective Observational Study
Acronym: VO2-EPOC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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