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

NCT02579525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

  • Shock; Septic
  • Critical Illness

Interventions

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Ville Pettilä, Prof · Helsinki University Hospital/ Bern University Hospital

  • Stephan Jakob, Prof, Dr · Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Finland
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579525 on ClinicalTrials.gov