Evidence map›Paper›PMID 30454042›Full record

ArticleTrials2018

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

Martin Unger, Andrea Morelli, Mervyn Singer, Peter Radermacher, Sebastian Rehberg, Helmut Trimmel, Michael Joannidis, Gottfried Heinz, Vladimír Cerny, Pavel Dostál and 12 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Beta-blockers in septic shock: What is new?Journal of intensive medicine · 2022
    Review
  8. Acute rate control in atrial fibrillation: an urgent need for the clinician.European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  9. Landiolol for refractory tachyarrhythmias in the intensive care unit: case reports.European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  10. Article
  11. Review
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 13 institutions in 5 countries.

Martin UngerAOP Orphan Pharmaceuticals AG, Wilhelminenstraße 91/II f, 1160, Vienna, Austria. martin.unger@aoporphan.com.ORCID http://orcid.org/0000-0002-9600-8618
Andrea MorelliDepartment of Anesthesiology and Intensive Care, University Hospital La Sapienza, Policlinico Umberto I, Rome, Italy.
Mervyn SingerIntensive Care Medicine, University College London, London, UK.
Peter RadermacherInstitute of Anesthesiologic Pathophysiology and Process Engineering, Ulm University Hospital, Ulm, Germany.
Sebastian RehbergDepartment of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Greifswald, Greifswald, Germany.
Helmut TrimmelDepartment of Anesthesiology, Emergency Medicine and General Intensive Care, State Hospital Wiener Neustadt, Wiener Neustadt, Austria.
Michael JoannidisDivision of Emergency Medicine and Intensive Care, Department Internal Medicine, Medical University Innsbruck, Innsbruck, Austria.
Gottfried HeinzDepartment of Internal Medicine II, Division of Cardiology, Intensive Care Unit, Medical University General Hospital, Vienna, Austria.
Vladimír CernyDepartment of Anesthesiology, Perioperative Medicine and Intensive Care, Masaryk Hospital, Usti Nad Labem, Czech Republic.
Pavel DostálDepartment of Anesthesiology, Resuscitation and Intensive Medicine, University Hospital Hradec Králové, Hradec Králové, Czech Republic.
Christian SiebersDepartment of Anesthesiology, University Hospital Munich, Munich, Germany.
Fabio GuarracinoDepartment of Anesthesiology and Resuscitation 5, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Francesca PratesiDepartment of Anesthesiology and Resuscitation 6, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Gianni BiancofioreDivision of Transplant Anesthesia and Critical Care, University School of Medicine Pisa, Pisa, Italy.
Massimo GirardisDepartment of Anesthesia and Intensive Care, University Hospital of Modena, Modena, Italy.
Pavla KadlecovaAixial s.r.o, Brno, Czech Republic.
Olivier BouvetAmomed Pharma GmbH, Vienna, Austria.
Michael ZörerAOP Orphan Pharmaceuticals AG, Wilhelminenstraße 91/II f, 1160, Vienna, Austria.
Barbara Grohmann-IzayAOP Orphan Pharmaceuticals AG, Wilhelminenstraße 91/II f, 1160, Vienna, Austria.
Kurt KrejcyAOP Orphan Pharmaceuticals AG, Wilhelminenstraße 91/II f, 1160, Vienna, Austria.
Christoph KladeAOP Orphan Pharmaceuticals AG, Wilhelminenstraße 91/II f, 1160, Vienna, Austria.
Günther KrumplAOP Orphan Pharmaceuticals AG, Wilhelminenstraße 91/II f, 1160, Vienna, Austria.
AOP Orphan (Austria) · ATAzienda Ospedaliera Universitaria Pisana · ITFachhochschule Wiener Neustadt · ATInnsbruck Medical University · ATLMU Klinikum · DEPoliclinico Umberto I · ITUniversitätsmedizin Greifswald · DEUniversity College London · GBUniversity Hospital Hradec Králové · CZUniversity Hospital Ulm · DEUniversity of Modena and Reggio Emilia · ITUniversity of Pisa · ITVienna General Hospital · AT

Funding

Amomed Pharma GmbH None
6 · The paper itself

Abstract

backgroundIn patients with septic shock, the presence of an elevated heart rate (HR) after fluid resuscitation marks a subgroup of patients with a particularly poor prognosis. Several studies have shown that HR control in this population is safe and can potentially improve outcomes. However, all were conducted in a single-center setting. The aim of this multicenter study is to demonstrate that administration of the highly beta1-selective and ultrashort-acting beta blocker landiolol in patients with septic shock and persistent tachycardia (HR ≥ 95 beats per minute [bpm]) is effective in reducing and maintaining HR without increasing vasopressor requirements.

methodsA phase IV, multicenter, prospective, randomized, open-label, controlled study is being conducted. The study will enroll a total of 200 patients with septic shock as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria and tachycardia (HR ≥ 95 bpm) despite a hemodynamic optimization period of 24-36 h. Patients are randomized (1:1) to receive either standard treatment (according to the Surviving Sepsis Campaign Guidelines 2016) and continuous landiolol infusion to reach a target HR of 80-94 bpm or standard treatment alone. The primary endpoint is HR response (HR 80-94 bpm), the maintenance thereof, and the absence of increased vasopressor requirements during the first 24 h after initiating treatment. DISCUSSION: Despite recent studies, the role of beta blockers in the treatment of patients with septic shock remains unclear. This study will investigate whether HR control using landiolol is safe, feasible, and effective, and further enhance the understanding of beta blockade in patients with septic shock.

trial registrationEU Clinical Trials Register; EudraCT, 2017-002138-22 . Registered on 8 August 2017.

Indexed as

Intensive Care UnitsAdrenergic beta-AntagonistsAnti-Arrhythmia AgentsBlood PressureClinical Trials, Phase IV as TopicEuropeHeart RateHumansMorpholinesMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicShock, SepticTime FactorsTreatment OutcomeUreaAdrenergic beta-AntagonistsAnti-Arrhythmia AgentslandiololMorpholinesUreaVasoconstrictor AgentsBeta-blockerLandiololRandomized controlled trialSepsisSeptic shockTachycardia

Identifiers

PMID30454042
PMCPMC6245811
OpenAlexW2900536301

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.