Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock — TARTARE-2S  

Critical Illness Clinical Trial

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

Status Completed

Clinical 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.

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:

1. Intervention group- Targeted tissue perfusion guided (TTP) - care.

2. 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.

Clinical Trial 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

1. capillary refill time (CRT) / <3 sec/ every hour

2. skin mottling / absent / every hour

3. arterial lactate / <2.0 mmol/l/ per 2hr

4. peripheral temperature/ warm /every hour

5. urine output/ ≥0.5 mL/kg per hour/ every hour

6. 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

7. Continuous mixed venous saturation (SvO2) >65%, if available

Control group - Macrocirculatory targets guided (MCG) standard care Primary targets

1. 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)

2. 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

3. Urine output ≥ 0.5 mL/kg/h/ hourly Secondary target

4. Continuous SvO2 >65%, if available ;

Related Conditions & MeSH terms

• Critical Illness
• Shock
• Shock, Septic
• Shock; Septic

• NCT number: NCT02579525
• Study type: Interventional
• Source: Helsinki University Central Hospital
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Completion date: December 31, 2022