Clinical trial NCT06930443: Oxygen Consumption, Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass
Official title: Oxygen Consumption, Early Postoperative Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass
Keywords: cardiac surgery
cardiopulmonary bypass
postoperative care
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective cardiac surgery at a university hospital

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* Combined, redo or annuloplasty procedures
* Surgical procedures involving other vascular cannulation than standard direct, such as bicaval or femoral cannulation
* Preoperative hyperlactatemia (\>2mmol/L) or anaemia (Hb \<90 g/dL)
* Preoperative need for supplementary oxygen or ICU care
* Consent not obtainable.

Primary outcomes:
measure: Difference in oxygen consumption in early postoperative hypoperfusion
timeFrame: 0-4 hours after surgery
Secondary outcomes:
measure: Evaluation of hypoperfusion parameters as predictors of postoperative oxygen consumption
timeFrame: 0-24 hours after surgery
measure: Evaluation of oxygen delivery and consumption during cardiopulmonary bypass as predictors of postoperative oxygen consumption
timeFrame: 0-4 hours during and after surgery
measure: Evaluation of organ injury biomarkers as predictors of postoperative oxygen consumption
timeFrame: Preoperative and the day after surgery
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Unit for Cardiothoracic Surgery, Dept. of Surgical Sciences, Uppsala University
name: Laila Hellgren Johanssson, MD PhD Associate Professor
role: STUDY_DIRECTOR
References: