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

NCT06930443 | Recruiting

• 2 other identifiers: FOU2025-00095284709
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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. 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. 2.How is oxygen consumption linked to signs of poor blood flow and organ injury (such as heart, kidney, liver, brain, and gut damage)?

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass

Keywords

cardiac surgery; cardiopulmonary bypass; postoperative care

Outcome Measures

Primary Outcomes (1)

• Difference in oxygen consumption in early postoperative hypoperfusion

  Difference in oxygen consumption (VO2I via indirect calorimetry) in ml min-1 m-2 between patients with and without early hyperlactatemia (\>2mmol/L)

  0-4 hours after surgery

Secondary Outcomes (3)

• Evaluation of hypoperfusion parameters as predictors of postoperative oxygen consumption

  0-24 hours after surgery

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

  0-4 hours during and after surgery

• Evaluation of organ injury biomarkers as predictors of postoperative oxygen consumption

  Preoperative and the day after surgery

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery at a university hospital

You may qualify if:

• Elective cardiac surgery requiring cardiopulmonary bypass

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial and central venous blood gases, blood gases from cardiopulmonary bypass circuit Blood samples for organ injury markers

MeSH Terms

Interventions

Oxygen Consumption

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Laila Hellgren Johanssson, MD PhD Associate Professor

  Unit for Cardiothoracic Surgery, Dept. of Surgical Sciences, Uppsala University

  STUDY DIRECTOR

Central Study Contacts

Julia Jakobsson MD PhD

CONTACT

+46-18-610 00 00; julia.o.jakobsson@akademiska.se

Olle Lönnemark MD

CONTACT

+46 -18-610 00 00; olle.lonnemark@akademiska.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Consultant Cardiothoracic anaesthesia and intensive care

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 16, 2025
• Study Start: May 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

SE (1)