Optimal Oxygenation in the Intensive Care Unit

NCT02321072 | Completed Phase 4

• 2 other identifiers: 2014/4592014-003468-19
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 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. 2.To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic and the normoxic patients.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

oxygen; hypoxia; hyperoxia; critical care; intensive care

Outcome Measures

Primary Outcomes (1)

• Daily Delta Sequential Organ Failure Assessment Score

  The primary endpoint will be cumulative daily delta SOFA score (CDDS) from day 1 to day 14, calculated as the sum of \[daily SOFA score minus admission SOFA score\] from day 2 to day 14. Daily SOFA score is calculated as the total of maximum scores for each organ system excluding respiratory system (because of possible PaO2/FiO2 distortion). For patients discharged from the ICU, SOFA score will be registered as 0 from the day of discharge to day 14. Death in the ICU will be registered as a score of 20 (maximum) from the day of death to day 14.

  14 days

Secondary Outcomes (14)

• total maximum SOFA score minus SOFA score on admission

  14 days

• SOFA rate of decline

  14 days

• Total maximum SOFA score, total maximum SOFA score minus SOFA score on admission, SOFA rate of decline

  14 days

• Mortality

  14 days, in-ICU (max 90 days), in-hospital (max 90 days)

• Hypoxic events (PaO2 <55 mmHg)

  14 days

Study Arms (2)

High-normal PaO2

ACTIVE COMPARATOR

In patients requiring respiratory monitoring, supplemental oxygen is titrated to achieve a PaO2 of 120 mmHg (16 kPa), range 105-135 mmHg (14-18 kPa).

Drug: Oxygen

Low-normal PaO2

ACTIVE COMPARATOR

In patients requiring respiratory monitoring, supplemental oxygen is titrated to achieve a target PaO2 of 75 mmHg (10 kPa), range 60-90 mmHg (8-18 kPa).

Drug: Oxygen

Interventions

Oxygen DRUG

High-normal PaO2; Low-normal PaO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Tergooi Hospital: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 37700687 DERIVED

• 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.

  PMID: 34463696 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Hypoxia; Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• A.M.E. de Man, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Intensivist

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 22, 2014
• Study Start: February 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

NL (1)