Optimal Oxygenation in the Intensive Care Unit

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• ≥2 positive SIRS-criteria:

• Temperature >38 deg.C or hypothermia <36 deg.C

• Heart rate >90 bpm

• Respiratory rate >20 /min or pCO2 <32 mmHg (4.3 kPa)

• Number of leucocytes >12 x 10^9/l of <4 x 10^9/l of >10% bands

• Within 12 hours of admittance to the ICU

• Expected stay of more than 48 hours as estimated by the attending physician

Exclusion Criteria:

• Elective surgery

• Carbon monoxide poisoning

• Cyanide intoxication

• Methemoglobinemia

• Sickle cell anemia

• Severe pulmonary arterial hypertension (WHO class III or IV)

• Known severe Acute Respiratory Distress Syndrome (ARDS) (PaO2/FiO2 ≤100 mmHg and PEEP ≥ 5 cm H2O)

• Known cardiac right to left shunting

• Pregnancy

• Severe Chronic Obstructive Pulmonary Disease (COPD) (Gold class III or IV) or other severe chronic pulmonary disease

• Patients participating in other interventional trials