Shock; SepticTARTARE-2SNCT02579525
Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock
A study testing Hemodynamical treatment TTP and Hemodynamical treatment MCG in people with Shock; Septic and Critical Illness, run by Helsinki University Central Hospital at 2 sites in 2 countries.
Trial summary
Background: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shock; Septic, Critical Illness
- What is being tested?
- Hemodynamical treatment TTP and Hemodynamical treatment MCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock defined as
- Septic infection AND
- systemic mean blood pressure > 65 mmHg requiring any dose of vasopressors (norepinephrine, vasopressin) despite adequate fluid resuscitation (minimum of 20 ml/kg crystalloids) AND
- Elevated lactate ≥ 3.0 mmol/L with suspected hypoperfusion
Who cannot join
- 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
- present or suspected myocardial ischemia
- acute pulmonary embolism
- terminal illness and not considered for full intensive care support
- use of extra-corporeal membrane oxygenation (ECMO)
Show all 13Show fewer
- known liver disease - Child-Pugh -Class B or C
- confirmed chronic kidney disease known on admission
- known to be pregnant or lactating
- more than 4 hours from fulfilled inclusion criteria to randomization
- another probable cause of hyperlactatemia
- patients transferred from another ICU
- patients with active haematological malignancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock [TARTARE-2S]- A Multicentre Randomized Controlled Trial
Background: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data.
Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target guided standard care.
Read more
Design: A prospective phase II two-parallel-group open-label randomized controlled trial
Interventions:
- Intervention group- Targeted tissue perfusion guided (TTP) - care.
- Control group - Macrocirculatory - guided (MCG) care.
Randomization: 1:1 stratified according to the site and presence or absence of known hypertension.
Trial size: 200 randomised patients in 4 ICUs.
Read the detailed description
Study hypothesis: Targeting at clinical tissue perfusion (in the TTP arm) will decrease the use and untoward effects of vasopressors, and result in more days alive in 30-days without vasopressor or inotropic support and without lactatemia, in comparison with standard clinical care with preference of macrocirculatory targets (MCG arm).
Intervention group - Targeted tissue perfusion (TTP) care:
Primary targets /registration period
- capillary refill time (CRT) / <3 sec/ every hour
- skin mottling / absent / every hour
- arterial lactate / <2.0 mmol/l/ per 2hr
- peripheral temperature/ warm /every hour
- urine output/ ≥0.5 mL/kg per hour/ every hour
- mean arterial pressure (MAP) 50-65 mmHg (minimum as a safety limit)/ continuous
- if previous hypertension 65- 70 mmHg
- if oliguria 2-hour trial 75-80 mmHg (If diuresis better, continue 2hr and re-evaluate) Secondary target
- Continuous mixed venous saturation (SvO2) >65%, if available
Control group - Macrocirculatory targets guided (MCG) standard care Primary targets
- Mean arterial pressure (MAP) 65-75 mmHg /continuous ** if previous hypertension 75-80 mmHg *** if oliguria < 0.3 ml/kg, 2-hour trial 85-90 mmHg (If diuresis better, continue 2hr and re-evaluate)
- Central venous pressure (CVP)/hourly, Adequate fluid therapy is indicated to restore clinical hypovolemia up to the recommended CVP-level of 8-12 mmHg, if needed
- Urine output ≥ 0.5 mL/kg/h/ hourly Secondary target
- Continuous SvO2 >65%, if available
- Conditions
- Shock; Septic, Critical Illness
- Being tested
- Hemodynamical treatment TTP, Hemodynamical treatment MCG
- Keywords
- septic shock, tissue perfusion, macrocirculatory, mean arterial pressure, vasopressor use, days alive free of organ support
- Medical subject headings
- Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamical treatment TTPOther
Based on capillary refilling time, peripheral temperature, mottling, diuresis, MAP safety limit monitoring
Hemodynamical treatment MCGOther
Based on MAP, CVP, urine output monitoring
| Study group | Role | What they receive |
|---|---|---|
| Targeted tissue perfusion guidance (TTP) | Experimental | TTP-guidance based on clinical signs of peripheral perfusion. Receives: Other: Hemodynamical treatment TTP |
| Macrocirculatory - guidance (MCG) | Active comparator | MCG-guidance based on recommended macrocirculatory parameters. Receives: Other: Hemodynamical treatment MCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive in 30 days- without vasopressors/ inotropes or hyperlactatemia
- Days alive in 30 days with normal arterial blood lactate ( first confirmed value of < 2 mmol/L) AND without any inotropic or vasopressor agent
Measured: 30 days
Secondary outcomes (10)
Time to normalization of arterial blood lactate
Measured: 30 days
Days alive with normal arterial blood lactate in 30 days
Measured: 30 days
Days alive without any inotropic or vasopressor agent in 30 days
Measured: 30 days
Days alive without renal replacement therapy (RRT) in 30 days
Measured: 30 days
Days alive without mechanical ventilation in 30 days
Measured: 30 days
Days alive without any organ support (mechanical ventilation, renal-replacement therapy, vasopressor/ inotropic agents) in 30 days
Measured: 30 days
New acute kidney injury (AKI) (Kdigo stages I-III)
Measured: 30 days
Days alive outside hospital in 90 days
Measured: 90 days
Total amount of norepinephrine given up to day 5
Measured: 5 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shock; SepticStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Ville Pettilä, Helsinki University Central Hospital
- Investigators
- Ville Pettilä, Prof, Principal investigator, Helsinki University Hospital/ Bern University HospitalStephan Jakob, Prof, Dr, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579525
- Sponsor's protocol ID
- TARTARE-2S-01
- Acronym
- TARTARE-2S
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2015
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Varis E, Pettila V, Poukkanen M, Jakob SM, Karlsson S, Perner A, Takala J, Wilkman E; FINNAKI Study Group. Evolution of Blood Lactate and 90-Day Mortality in Septic Shock. A Post Hoc Analysis of the FINNAKI Study. Shock. 2017 May;47(5):574-581. doi: 10.1097/SHK.0000000000000772.
PubMed 27755509Pettila V, Merz T, Wilkman E, Perner A, Karlsson S, Lange T, Hastbacka J, Hjortrup PB, Kuitunen A, Jakob SM, Takala J. 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. Trials. 2016 Aug 2;17:384. doi: 10.1186/s13063-016-1515-x.
PubMed 27484695
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock [TARTARE-2S]- A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02579525
- Acronym / sponsor ID
- TARTARE-2S / TARTARE-2S-01
- Conditions
- Shock; Septic, Critical Illness
- Keywords
- septic shock, tissue perfusion, macrocirculatory, mean arterial pressure, vasopressor use, days alive free of organ support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data.
Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target guided standard care.
Design: A prospective phase II two-parallel-group open-label randomized controlled trial
Interventions:
- Intervention group- Targeted tissue perfusion guided (TTP) - care.
- Control group - Macrocirculatory - guided (MCG) care.
Randomization: 1:1 stratified according to the site and presence or absence of known hypertension.
Trial size: 200 randomised patients in 4 ICUs.
Detailed description
Study hypothesis: Targeting at clinical tissue perfusion (in the TTP arm) will decrease the use and untoward effects of vasopressors, and result in more days alive in 30-days without vasopressor or inotropic support and without lactatemia, in comparison with standard clinical care with preference of macrocirculatory targets (MCG arm).
Intervention group - Targeted tissue perfusion (TTP) care:
Primary targets /registration period
- capillary refill time (CRT) / <3 sec/ every hour
- skin mottling / absent / every hour
- arterial lactate / <2.0 mmol/l/ per 2hr
- peripheral temperature/ warm /every hour
- urine output/ ≥0.5 mL/kg per hour/ every hour
- mean arterial pressure (MAP) 50-65 mmHg (minimum as a safety limit)/ continuous
- if previous hypertension 65- 70 mmHg
- if oliguria 2-hour trial 75-80 mmHg (If diuresis better, continue 2hr and re-evaluate) Secondary target
- Continuous mixed venous saturation (SvO2) >65%, if available
Control group - Macrocirculatory targets guided (MCG) standard care Primary targets
- Mean arterial pressure (MAP) 65-75 mmHg /continuous ** if previous hypertension 75-80 mmHg *** if oliguria < 0.3 ml/kg, 2-hour trial 85-90 mmHg (If diuresis better, continue 2hr and re-evaluate)
- Central venous pressure (CVP)/hourly, Adequate fluid therapy is indicated to restore clinical hypovolemia up to the recommended CVP-level of 8-12 mmHg, if needed
- Urine output ≥ 0.5 mL/kg/h/ hourly Secondary target
- Continuous SvO2 >65%, if available
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted tissue perfusion guidance (TTP) | Experimental | Other: Hemodynamical treatment TTPTTP-guidance based on clinical signs of peripheral perfusion. |
| Macrocirculatory - guidance (MCG) | Active comparator | Other: Hemodynamical treatment MCGMCG-guidance based on recommended macrocirculatory parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Septic shock defined as
Key exclusion criteria (13 listed)
- 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
- present or suspected myocardial ischemia
- acute pulmonary embolism
- terminal illness and not considered for full intensive care support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamical treatment TTPBased on capillary refilling time, peripheral temperature, mottling, diuresis, MAP safety limit monitoring | Other | Targeted tissue perfusion guidance (TTP) |
| Hemodynamical treatment MCGBased on MAP, CVP, urine output monitoring | Other | Macrocirculatory - guidance (MCG) |
Primary outcome
Days alive in 30 days- without vasopressors/ inotropes or hyperlactatemia
Time frame: 30 days
• Days alive in 30 days with normal arterial blood lactate ( first confirmed value of < 2 mmol/L) AND without any inotropic or vasopressor agent
10 secondary outcomes
Time to normalization of arterial blood lactate
Time frame: 30 days
Days alive with normal arterial blood lactate in 30 days
Time frame: 30 days
Days alive without any inotropic or vasopressor agent in 30 days
Time frame: 30 days
Days alive without renal replacement therapy (RRT) in 30 days
Time frame: 30 days
Days alive without mechanical ventilation in 30 days
Time frame: 30 days
Days alive without any organ support (mechanical ventilation, renal-replacement therapy, vasopressor/ inotropic agents) in 30 days
Time frame: 30 days
New acute kidney injury (AKI) (Kdigo stages I-III)
Time frame: 30 days
Days alive outside hospital in 90 days
Time frame: 90 days
Total amount of norepinephrine given up to day 5
Time frame: 5 days
Number/ total number of the following adverse reactions
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 27755509Varis E, Pettila V, Poukkanen M, Jakob SM, Karlsson S, Perner A, Takala J, Wilkman E; FINNAKI Study Group. Evolution of Blood Lactate and 90-Day Mortality in Septic Shock. A Post Hoc Analysis of the FINNAKI Study. Shock. 2017 May;47(5):574-581. doi: 10.1097/SHK.0000000000000772.
- Background: PubMed 27484695Pettila V, Merz T, Wilkman E, Perner A, Karlsson S, Lange T, Hastbacka J, Hjortrup PB, Kuitunen A, Jakob SM, Takala J. 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. Trials. 2016 Aug 2;17:384. doi: 10.1186/s13063-016-1515-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ville Pettilä, Prof principal investigator
Helsinki University Hospital/ Bern University Hospital
Stephan Jakob, Prof, Dr principal investigator
Bern University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamical treatment TTP and Hemodynamical treatment MCG in people with Shock; Septic and Critical Illness, run by Helsinki University Central Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive in 30 days- without vasopressors/ inotropes or hyperlactatemia (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02579525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.