The effect of increased oxygen levels on organ failure and survival in critically ill patients with systemic inflammatio

Conditions: Intensive Care patients with the systemic inflammatory response syndrome
MedDRA version: 18.1Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 100000004867
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2014-003468-19-NL

Lead Sponsor: VU University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Age =18 years
-=2 positive SIRS-criteria:
Temperature >38oC or hypothermia <36oC
Heart rate >90 bpm
Respiratory rate >20 /min or pCO2 <32 mmHg (4.3 kPa)
Number of leucocytes >12 x 109/l of <4 x 109/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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

-Elective surgery
-Carbon monoxide poisoning
-Cyanide intoxication
-Methemoglobinemia
-Pregnancy
-Severe COPD (Gold class III or IV) or other sever chronic pulmonary disease
-Sickle cell anemia
-Known pulmonary arterial hypertension (WHO class III or IV)
-Known cardiac right to left shunting

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the short- and long-term effect of different PaO2 targets on circulatory status, organ dysfunction and outcome.;Secondary Objective: To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic patients and the normoxemic groups. <br>;Primary end point(s): The cumulative ? Sequential Organ Failure (SOFA) score within the first 14 days of inclusion;Timepoint(s) of evaluation of this end point: First 14 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary parameters will include time spent in the assigned PaO2 range, hypoxic episodes (PaO2 <55 mmHg), vasopressor / inotrope requirements (max dose every 24 hours), need for renal replacement therapy and fluid balances (every 24 hours). Furthermore, oxidative stress parameters F2-isoprostanes will be determined (on day 1, 2 and 4) and as clinical endpoints: duration of mechanical ventilation, lung injury score, ventilator-free days, length of stay (in ICU, in hospital) and mortality (ICU and hospital). ;Timepoint(s) of evaluation of this end point: First 14 days