LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

Limiting perioperative tachycardia (aiming for a heart rate \<90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing elective non-cardiac surgery defined as intermediate or high-risk by the 2022 european society of cardiology (ESC) guidelines

surgery performed under general anesthesia;

expected length of hospital stay ≥ 24 hours;

age ≥ 45 years;

Disqualifiers

unable to consent or follow study procedures;

absolute contraindications for exercise testing;

pregnancy or intention to become pregnant;

active cardiac conditions (such as unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Landiolol

    Drug

    The main dose range is 1-40 mcg/kg/min, titrated to the effect on heart rate aiming for a heart rate of below 90 beats per minute throughout. This dose can be decreased to 0 if heart rate stays below target.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: LandiololExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time perioperative heart rate in target range

As a marker of successful intervention, time perioperative heart rate in target range (below 90 beats per minute) will serve as primary outcome. The intervention is considered feasible if the heart rate stays at least 90% of the time within the target range during the perioperative period.

Time frame
From induction of anaesthesia until discharge from postanaesthetic care unit [percent of time heart rate within target range (<90 beats per minute)]

Secondary outcomes

1

Perioperative heart rate

Perioprative heart rate will be calculated as time weighted area under the curve for the perioperative period.

Time frame
From induction of anaesthesa until discharge from postanaesthetic care unit [heart rate in beats per minute * minutes ]
2

Dose of vasopressors

Total dose of vasopressors such as noradrenalin, ephedrine or phenylephrine will be recorded in micrograms.

Time frame
Induction of anaesthesia until discharge from postanaeshetic care unit [mcg per recorded drug]
3

Length of postanaesthetic care unit stay

Lenght of postaenaesthetic care unit stay will be recorded in minutes.

Time frame
Admission to postanaesthetic care unit until discharge from postanaesthetic care unit [minutes]
4

Length of hospital stay

Length of hospital stay will be recorded in days.

Time frame
Admission to hospital until discharge from hospital [days]

Other outcomes

1

Major adverse cardio- and cerebrovascular events

Major adverse cardio- and cerebrovascular events (MACCE) include diagnosis of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia or angina, non-fatal stroke.

Time frame
30 days after surgery
2

All-cause death

This parameter serves to assess postoperative mortality.

Time frame
30 days after surgery
3

Quality of life (EQ-5D)

Quality of life will be assessed using the EQ-5D questionnaire. The EQ-5D questionnaire is a standardised health-related quality of life questionnaire developed by the EuroQol Group. It assesses five dimensions of health and results in an utility index score ranging from 0 (death) to 1 (perfect health).

Time frame
30 days after surgery
4

Comprehensive complication index

The comprehensive complication index is calculated as a sum of all complications weighted for their severity. It results in a continuous scale ranking the severity of any combination of complications from 0 (no complication) to 100 (death).

Time frame
30 days after surgery

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