Evidence map›Paper›PMID 27484695›Full record

Trial reportTrials2016

Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S): study protocol and statistical analysis plan for a randomized controlled trial.

Ville Pettilä, Tobias Merz, Erika Wilkman, Anders Perner, Sari Karlsson, Theis Lange, Johanna Hästbacka, Peter Buhl Hjortrup, Anne Kuitunen, Stephan M Jakob and 1 more

2 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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.

NCT02579525 nacompletednot on this map

Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock [TARTARE-2S]- A Multicentre Randomized Controlled Trial

TypeinterventionalSponsorHelsinki University Central HospitalRan2016 to 2022Enrolled200ConditionsShock, Septic, Critical IllnessArmsHemodynamical treatment TTP, Hemodynamical treatment MCG
NCT06125184 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Effect of Vasopressin on Kidney and Cardiac Function in Previously Hypertensive Patients With Septic Shock: A Randomized Clinical Trial

TypeinterventionalSponsorPontificia Universidad Catolica de ChileRan2022 to 2025Enrolled50ConditionsKidney Injury, Acute, Cardiac Function FailedArmsVasopressor test
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Observational
  6. Review
  7. Review
  8. 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

11 authors at 6 institutions in 3 countries.

Ville PettiläDepartment of Intensive Care Medicine, Bern University Hospital (Inselspital), University of Bern, Bern, Switzerland. ville.pettilae@insel.ch.
Tobias MerzDepartment of Intensive Care Medicine, Bern University Hospital (Inselspital), University of Bern, Bern, Switzerland.
Erika WilkmanDivision of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Anders PernerDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Sari KarlssonDepartment of Intensive Care, Tampere University Hospital, Tampere, Finland.
Theis LangeCRIC, Center of Research for Intensive Care, Copenhagen, Denmark.
Johanna HästbackaDivision of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Peter Buhl HjortrupDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Anne KuitunenDepartment of Intensive Care, Tampere University Hospital, Tampere, Finland.
Stephan M JakobDepartment of Intensive Care Medicine, Bern University Hospital (Inselspital), University of Bern, Bern, Switzerland.
Jukka TakalaDepartment of Intensive Care Medicine, Bern University Hospital (Inselspital), University of Bern, Bern, Switzerland.
University Hospital of Bern · CHCentre for Research in Intensive Care · DKTampere University Hospital · FIUniversity of Helsinki · FICopenhagen University Hospital · DKUniversity of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeptic shock has a 90-day mortality risk of up to 50 %. The hemodynamic targets, including mean arterial pressure (MAP) are not based on robust clinical data. Both severe hypotension and high doses of vasopressors may be harmful. Hence, re-evaluation of hemodynamic targets in septic shock is relevant. METHODS/

designThe targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S) trial is a prospective, two-parallel-group, randomized, open-label, multicenter trial with assessor-blinded outcome evaluation. We will randomize at least 200 patients with septic shock in four European intensive care units (ICUs) to test whether a tissue perfusion-guided treatment strategy based on capillary refill time, peripheral temperature, arterial lactate concentrations, and accepting lower MAP levels, leads to a faster resolution of shock than macrocirculation target-guided standard care. The primary outcome measure is days alive in 30 days with normal arterial blood lactate (first value of <2 mmol/L) and without any inotropic or vasopressor agent. Secondary outcomes include individual components of the primary outcome, days alive without renal replacement, days alive without mechanical ventilation in 30 days, and new acute kidney injury. The sample size enables detection of a 13.5-h difference in the primary outcome with a type 1 error of 5 % and power of 80 %, assuming 25 % mortality and a mean of 650 h (SD 30) among the 30-day survivors. After 150 included patients the statistician masked for allocation group will recalculate the sample size potentially increasing the sample up to 300. The Data Safety and Monitoring Board (DSMB) will review the safety data after 100 patients. DISCUSSION: The TARTARE-2S trial will provide important clinical data on treatment targets in septic shock, evaluating the impact of clinical tissue perfusion-guided hemodynamic treatment on a surrogate outcome combining resolution of shock (hyperlactatemia and vasopressors/inotropes), and 30-day mortality.

trial registrationClinicalTrials.gov: NCT02579525 . Registered on 19 October 2015.

Indexed as

Fluid TherapyModels, StatisticalRenal Replacement TherapyRespiration, ArtificialArterial PressureBiomarkersCardiotonic AgentsCardiovascular AgentsClinical ProtocolsCombined Modality TherapyData Interpretation, StatisticalEuropeFeasibility StudiesHemodynamicsHumansLactic AcidBiomarkersCardiotonic AgentsCardiovascular AgentsLactic AcidVasoconstrictor AgentsCritical illnessLactateMortalitySeptic shockTissue perfusionVasopressor

Identifiers

PMID27484695
PMCPMC4971711
OpenAlexW2477287435

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.