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Recruiting NCT06930443

Oxygen Consumption, Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass

Observational Cardiac Surgery Requiring Cardiopulmonary Bypass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxygen consumption measurement.
Who it may be relevant to
Registry conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Oxygen Consumption, Early Postoperative Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass: a Prospective Observational Study

Overview

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.

Interventions

  • Other Oxygen consumption measurement
    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.

Primary outcome measures

  • Difference in oxygen consumption in early postoperative hypoperfusion [Time frame: 0-4 hours after surgery]
Secondary outcome measures (3)
  • Evaluation of hypoperfusion parameters as predictors of postoperative oxygen consumption [Time frame: 0-24 hours after surgery]
  • Evaluation of oxygen delivery and consumption during cardiopulmonary bypass as predictors of postoperative oxygen consumption [Time frame: 0-4 hours during and after surgery]
  • Evaluation of organ injury biomarkers as predictors of postoperative oxygen consumption [Time frame: Preoperative and the day after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Uppsala University Hospital — Uppsala

Identifiers

NCT: NCT06930443 · FOU2025-00095 · 284709

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗