Optimal Oxygenation in the Intensive Care Unit

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.

Timeline

Start

2015-02

Primary completion

2019-01

Completion

2019-05

Publications

• Klitgaard TL, Schjorring OL, Nielsen FM, Meyhoff CS, Perner A, Wetterslev J, Rasmussen BS, Barbateskovic M. Higher versus lower fractions of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD012631. doi: 10.1002/14651858.CD012631.pub3.
• Gelissen H, de Grooth HJ, Smulders Y, Wils EJ, de Ruijter W, Vink R, Smit B, Rottgering J, Atmowihardjo L, Girbes A, Elbers P, Tuinman PR, Oudemans-van Straaten H, de Man A. Effect of Low-Normal vs High-Normal Oxygenation Targets on Organ Dysfunction in Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):940-948. doi: 10.1001/jama.2021.13011.

Drugs

Indications