Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock
Condition: Shock; Septic; Critical Illness
MeSH terms: Shock, Septic; Shock; Critical Illness
Study type: Interventional

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
    

Intervention name(s): Hemodynamical treatment TTP; Hemodynamical treatment MCG
Intervention type(s): Other; Other
Intervention description(s): Based on capillary refilling time, peripheral temperature, mottling, diuresis, MAP safety limit monitoring; Based on MAP, CVP, urine output monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: septic shock; tissue perfusion; macrocirculatory; mean arterial pressure; vasopressor use; days alive free of organ support