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

NCT ID: NCT06930443

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-05

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgery Requiring Cardiopulmonary Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julia Jakobsson

MD, PhD, Consultant Cardiothoracic anaesthesia and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laila Hellgren Johanssson, MD PhD Associate Professor

Role: STUDY_DIRECTOR

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

Locations

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Uppsala University Hospital

Uppsala, Sweden, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Julia Jakobsson MD PhD

Role: CONTACT

+46-18-610 00 00

Olle Lönnemark MD

Role: CONTACT

+46 -18-610 00 00

Facility Contacts

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Julia Jakobsson, MD PhD

Role: primary

+46186100000

Other Identifiers

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284709

Identifier Type: OTHER

Identifier Source: secondary_id

FOU2025-00095

Identifier Type: -

Identifier Source: org_study_id

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