Skip to main content

Advertisement

Table 2 Inclusion/exclusion criteria

From: Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial

Inclusion criteria 1. Informed consent  2. Age ≥ 18 years  3. Confirmed septic shock:   a. Confirmed or suspected infection   b. Acute increase of ≥ 2 points on SOFA Score   c. Need for continuous vasopressor therapy to maintain a mean arterial pressure (MAP) of > 65 mmHg despite adequate fluid resuscitation   d. Blood lactate > 2 mmol/L (18 mg/dL)a  4. Tachycardia and/or tachyarrhythmia with heart rate ≥ 95 bpm  5. Norepinephrine infusion rate ≥ 0.2 μg/kg/min at the time of study inclusion  6. Patients must have undergone a hemodynamic optimization period of at least 24 h but a maximum of 36 h, during which period they received continuous vasopressor treatment and standard treatment for septic shock according to the SSCG 2016 guidelines aPresence of blood lactate > 2 mmol/L (18 mg/dL) and increase of ≥ 2 points on SOFA score are mandatory for the diagnosis of septic shock, but must not necessarily be present at the time of study inclusion Exclusion criteria:  1. Any form of compensatory tachycardia  2. β-blocker treatment within 72 h before randomization  3. Sick sinus syndrome, or second or third degree AV block  4. Patients with any form of cardiac pacing  5. A known serious cardiovascular condition such as ischemic stroke or transient ischemic attack within the last six months, or pre-existing heart failure NYHA class III or IV  6. Cardiogenic shock  7. MAP < 65 mmHg  8. Known pulmonary hypertension  9. Known terminal illness other than septic shock with expected patient’s survival < 28 days  10. Known presence of an advanced condition to withhold life-sustaining treatment  11. Patients for whom a “Do Not Resuscitate” (DNR) order exists  12. Known sensitivity to any component of the study medication (e.g. landiolol, mannitol)  13. Participation in a clinical drug trial within 30 days before randomization  14. Any condition that, in the investigator’s opinion, makes the individual unsuitable for study participation (to be documented)  15. Pregnant or breast-feeding patients  16. Untreated pheochromocytoma
  1. NYHA New York Heart Association