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Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

ConditionsCoronary Artery DiseaseAortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

Open heart surgery, including coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) is associated with a significant risk of mortality.

This study is a randomized clinical trial with the purpose of investigating four different interventions on the primary endpoint 'days alive and outside of hospital within 90 days'.

The interventions are:

* Dexamethasone vs. placebo administered after induction of anesthesia. * Olanzapine vs. placebo administered prior to anesthesia. * A blood-flow targeted vs. a blod-pressure targeted hemodynamic strategy while the patient is on cardio-pulmonary bypass (CPB) * Low-tidal volume ventilation vs. no ventilation of the lungs while the patient is on CPB

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult, i.e., above 18 years of age

Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.

Disqualifiers

Acute surgery (i.e. off hours surgery)

Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.

Known endocarditis at time of screening

Previous participation in the trial

Trial design

Design model

Factorial

Treatments tested in this trial

  • Dexamethasone phosphate

    Drug

    See description of arms

  • Isotonic sodium chloride (0.9%)

    Drug

    See description of arms

  • Olanzapine 10 MG

    Drug

    Olanzapine tablet pre-hidden in capsule identical to the placebo tablet

  • Placebo capsule

    Drug

    capsule identical to capsule containing olanzapine

  • Flow-targeted hemodynamic management

    Procedure/Surgery

    See description of arms

  • Pressure-targeted hemodynamic management

    Procedure/Surgery

    See description of arms

  • Low tidal-volume ventilation

    Procedure/Surgery

    See description of arms

  • No ventilation

    Procedure/Surgery

    See description of arms

Treatment groups

1,200 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: DexamethasoneExperimental treatment 1 intervention
Group B: Placebo (for Dexamethasone)Placebo comparator 1 intervention
Group C: OlanzapineExperimental treatment 1 intervention
Group D: Placebo (for Olanzapine)Placebo comparator 1 intervention
Group E: Flow-targeted hemodynamic managementExperimental treatment 1 intervention
Group F: Pressure-targeted hemodynamic managementActive comparator 1 intervention
Group G: Low tidal-volume ventilationExperimental treatment 1 intervention
Group H: No ventilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Days alive and outside hospital

Time frame
90 days from surgery

Secondary outcomes

1

Time to composite outcome of death and major organ damage

Time in days to occurrence of any component in a composite secondary endpoint during follow-up consisting of 1. Death from any cause 2. Stroke, defined as persisting (\>24 hours) of any neurological symptoms of neurological dysfunction during the 6 months follow-up period. The diagnosis is determined by the treating physician. 3. Acute kidney injury requiring any type of renal replacement therapy during the follow-up period. 4. New onset or worsening heart failure, defined as persistent (\> 24 hours from initiation) need for vasopressor/inotropic hemodynamic support, need for mechanical circulatory support after surgery, inability to close the sternotomy due to hemodynamic instability after surgery or readmission for acute heart failure during follow-up.

Time frame
90 days
2

Number (fraction) of patients with severe post-operative complications during index admission, defined as a Clavien-Dindo class of 3 to 5.

The Clavien-Dindo classification runs from 1 to 5 with a higher score indicating more severe complications.

Time frame
During index admission up to 30 days after surgery. Outcome will be assessed upon hospital discharge.
3

Number (fraction) of patients with delirium, defined as a positive Confusion Assessment Method for the ICU (CAM-ICU) or wards (CAM).

Number (fraction) of patients with delirium during index admission will be reported. Outcome will be assessed daily until hospital discharge.

Time frame
During index admission up to 30 days after surgery.
4

Quality of Recovery-15 (QoR-15) score

The QoR-15 score includes 15 questions with each question being graded from 0-10.

Time frame
3 days or as soon as possible after surgery

Other outcomes

1

Surgical wound infection

Surgical wound infection including sternum infection and/or endocarditis, requiring antibiotics for \> 48 hours and/or surgical revision.

Time frame
Within 90 days
2

Sepsis

Sepsis, as defined by the Sepsis-3 criteria, requiring antibiotics for a minimum of 3 consecutive days. 3\)

Time frame
Within 90 days
3

Acute kidney injury

Acute kidney injury, as defined by the KDIGO criteria.

Time frame
Within 90 days
4

Myocardial infarction

Myocardial infarction, as defined by the Fourth Universal Definition of Myocardial Infarction.

Time frame
Within 90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov
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