TISSUE PERFUSION IN SEPTIC SHOCK

TARGETED TISSUE PERFUSION VERSUS MACROCIRCULATORY-GUIDED STANDARD CARE IN PATIENTS WITH SEPTIC SHOCK (TARTARE-2S) - TARTARE-2S

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005112-15-DK

Enrollment

150

Registered

2016-06-03

Start date

2016-09-29

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill adult patients with septic shock MedDRA version: 20.0 Level: LLT Classification code 10040050 Term: Sepsis NOS System Organ Class: 100000004862

Interventions

Trade Name: Noradrenalin SAD Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: NOREPINEPHRINE CAS Number: 51-41-2 Concentration unit: µg/kg microgram(s)/kilog

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infection (suspected or confirmed) AND 2. systemic mean blood pressure > 65 mmHg requiring any dose of vasopressors (norepinephrine, vasopressin) despite adequate fluid resuscitation (minimum of 20 ml/kg crystalloids) AND 3. Elevated lactate = 3.0 mmol/L with suspected hypoperfusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: • aged less than 18 or over 80 years • any other probable condition than sepsis affecting or expected to affect the central nervous system including post cardiac arrest • myocardial ischemia • acute pulmonary embolism • terminal illness and not considered for full intensive care support • use of extra-corporeal membrane oxygenation (ECMO) • known liver disease - Child-Pugh –Class B or C • known chronic kidney disease • known to be pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if tissue targeted monitoring/treatment compared to macrocircutory guided monitoring/treatment in septic shock patients increases days alive in 30 days without vasoactive drugs and without hyperlactatemia;Secondary Objective: To compare the trial arms regarding organ dysfunction, supportive treatments, and mortality.;Primary end point(s): Days alive in 30 days - with normal arterial blood lactate ( first confirmed value of < 2 mmol/L AND without any inotropic or vasopressor agent;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: To evaluate if tissue targeted monitoring/treatment compared to macrocircutory guided monitoring/treatment in septic shock patients increases days alive in 30 days without vasoactive drugs and without hyperlactatemia;Secondary Objective: To compare the trial arms regarding organ dysfunction, supportive treatments, and mortality.;Primary end point(s): Days alive in 30 days - with normal arterial blood lactate ( first confirmed value of < 2 mmol/L AND without any inotropic or vasopressor agent;Timepoint(s) of evaluation of this end point: 30 days

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures a. Time to normalization of lactate b. Days alive with normal lactate in 30 days c. Days alive without any inotropic or vasopressor agent in 30 days d. Days alive without RRT in 30 days e. Days alive without mechanical ventilation in 30 days f. Days alive without any organ support (mechanical ventilation, renalreplacement therapy) in 30 days g. New AKI according to the KDIGO classification (Stages I-III) h. Days alive outside hospital in 90 days i. Total amount of norepinephrine given up to day 5 j. Number/ total number of the following adverse reactions: ventricular tachycardia/ fibrillation atrial fibrillation myocardial infarction skin necrosis stroke secondary bowel ischemia limb ischemia numbers of serious adverse events Exploratory outcomes: k. All-cause mortality at day 90;Timepoint(s) of evaluation of this end point: 0 to 90 days.	—

Measure

Time frame

Secondary end point(s): Secondary outcome measures a. Time to normalization of lactate b. Days alive with normal lactate in 30 days c. Days alive without any inotropic or vasopressor agent in 30 days d. Days alive without RRT in 30 days e. Days alive without mechanical ventilation in 30 days f. Days alive without any organ support (mechanical ventilation, renalreplacement therapy) in 30 days g. New AKI according to the KDIGO classification (Stages I-III) h. Days alive outside hospital in 90 days i. Total amount of norepinephrine given up to day 5 j. Number/ total number of the following adverse reactions: ventricular tachycardia/ fibrillation atrial fibrillation myocardial infarction skin necrosis stroke secondary bowel ischemia limb ischemia numbers of serious adverse events Exploratory outcomes: k. All-cause mortality at day 90;Timepoint(s) of evaluation of this end point: 0 to 90 days.

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Countries

Denmark

Contacts

Public ContactDepartment of Intensive Care

Inselspital, Universitätspital Bern

Stephan.Jakob@insel.ch+41031 632 53 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026