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NCT Number: NCT06930443

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University Hospital

Uppsala, Sweden

Location status: Recruiting

Location contact

Julia Jakobsson, MD PhD

CONTACT

[email protected]

+46186100000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen consumption measurement

Other

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 outcomes

  1. Difference in oxygen consumption in early postoperative hypoperfusion

    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)

Secondary outcomes

  1. Evaluation of hypoperfusion parameters as predictors of postoperative oxygen consumption

    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:

    • Central venous oxygen saturation (ScvO2, %, central venous blood gas), 2) Arterial lactate (mmol/L, arterial blood gas), 3) Base excess (BE, mmol/L, arterial blood gas), 4) Venous-to-arterial CO2 difference (ΔPCO2, mmHg, arterial and central venous blood gas) and its ratio with arterial -central venous oxygen content.

    Clinical variables measured hourly or otherwise specified:

    • Heart rate (beats/min), 6) Mean arterial pressure (MAP, mmHg), 7) Central venous pressure (CVP, mmHg), 8) Vasopressor or inotrope requirement (Y/N, low-intermediate-high), 9) Urine output (mL/24 hours), and 10) net fluid balance (mL/24 hours).

    Additional explorative data analyses for hypothesis generating purposes can be performed.

  2. Evaluation of oxygen delivery and consumption during cardiopulmonary bypass as predictors of postoperative oxygen consumption

    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.

  3. Evaluation of organ injury biomarkers as predictors of postoperative oxygen consumption

    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.

    • Renal: Creatinine (mmol L-1), Estimated glomerular filtration rate; eGFR (ml min-1 1.73 m-2):
    • Cardiac: Troponin T; TnT, creatinine kinase-MB; CK-MB, probrain natriuretic peptide; Nt-proBNP (ng L-1)
    • Hepatic: Aspartate aminotransferase; ASAT, alanine aminotransferase; ALAT(mikrokat L-1)
    • Brain: Neurofilament light chain; NFL, Glial fibrillary acidic protein, GFAP (ng L-1)
    • Gut: Medium chain fatty acids; MCFA, Short chain fatty acids; SCFA, conjugated and non-conjugated bile acids (ng ml-1) Additional explorative data analyses for hypothesis generating purposes can be performed.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Jakobsson MD PhD

CONTACT

[email protected]

+46-18-610 00 00

Olle Lönnemark MD

CONTACT

[email protected]

+46 -18-610 00 00

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study title

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

Acronym: VO2-EPOC

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
May 11, 2025

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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