NCT02579525

Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Shock; Septic
• Critical Illness

Interventions

Type	Name	Description
OTHER	Hemodynamical treatment TTP	Based on capillary refilling time, peripheral temperature, mottling, diuresis, MAP safety limit monitoring
OTHER	Hemodynamical treatment MCG	Based on MAP, CVP, urine output monitoring

Timeline

• Start date: 2016-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-31
• First posted: 2015-10-19
• Last updated: 2023-03-01

Locations

2 sites across 2 countries: Finland, Switzerland