Overview

Optimal Oxygenation in the Intensive Care Unit

Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
Objectives: 1. To study the short- and long-term effect of two different PaO2 targets on circulatory status, organ dysfunction and outcome in patient admitted to the ICU with Systemic Inflammatory Response Syndrome (SIRS) criteria. 2. To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic and the normoxic patients. Study design: Randomized, prospective multicentre clinical trial Study population: Patients admitted to the Intensive Care unit with ≥ 2 positive SIRS-criteria and an expected ICU stay of more than 48 hours Intervention: Group 1: target PaO2 120 (105 - 135) mmHg (high-normal) Group 2: target PaO2 75 (60 - 90) mmHg (low-normal) Primary endpoints: The primary endpoint will be cumulative daily delta SOFA score (CDDS) from day 1 to day 14.
Phase:
Phase 4
Details
Lead Sponsor:
VU University Medical Center
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Tergooi Hospital
ZonMw: The Netherlands Organisation for Health Research and Development