Hypoxia Clinical Trial
— Oxy-PICUOfficial title:
A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Verified date | February 2018 |
Source | Great Ormond Street Hospital for Children NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A feasibility study to determine if it is possible to perform a safe, adequately powered, and affordable multi-centre study in critically ill children comparing current practice of liberal targets for systemic oxygen levels with more conservative targets.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 1, 2017 |
Est. primary completion date | June 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 39 Weeks to 15 Years |
Eligibility |
Inclusion Criteria: - less than 16 years and > 38 weeks corrected gestational age - receiving supplemental oxygen for abnormal gas exchange - emergency admission accepted to a participating paediatric intensive care unit (PICU) requiring mechanical ventilation within first 6 hours of face-to-face contact with PICU staff or transport team Exclusion Criteria: - recruited to Oxy-PICU in a previous admission - brain pathology/injury as a primary reason for admission (e.g traumatic brain injury, post-cardiac arrest, stroke, convulsive status epilepticus without aspiration) - known pulmonary hypertension - known or suspected sickle cell disease - known or suspected uncorrected congenital cardiac disease - End-of-life care plan in place with limitation of resuscitation - not expected to survive PICU admission - receiving long-term mechanical ventilation prior to this admission (non-invasive ventilation or invasive ventilation) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormond Street Hospital for Children | London | |
United Kingdom | St Mary's Hospital | London | |
United Kingdom | Southampton General Hospital | Southampton |
Lead Sponsor | Collaborator |
---|---|
Great Ormond Street Hospital for Children NHS Foundation Trust | Intensive Care National Audit & Research Centre, St Mary's Hospital, London, University College, London, University Hospital Southampton NHS Foundation Trust, University of Southampton |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of eligible patients recruited per site per month | Baseline | ||
Secondary | Proportion of parents/legal representatives refusing deferred consent | Through study completion, an average of 24 hours | ||
Secondary | Proportion of eligible patients randomised | Baseline | ||
Secondary | Distribution of time to randomisation | Baseline | ||
Secondary | Proportion of systemic oxygen saturations within the target range in each group | Through study completion, an average of 72 hours | ||
Secondary | Proportion of patients in each arm requiring other treatments influencing tissue oxygen delivery (blood transfusion, inotropic support) | Through study completion, an average of 72 hours | ||
Secondary | Length of ventilation - proportion of randomised patients with outcome available in each group | Through study completion, an average of 2 days | ||
Secondary | Length of ventilation - mean (standard deviation) in each group | Through study completion, an average of 2 days | ||
Secondary | Length of ventilation - median and quartiles in each group. | Through study completion, an average of 2 days | ||
Secondary | Observed adverse events | 28 days | ||
Secondary | Time taken for data collection and entry | 28 days | ||
Secondary | Measurement of ischemia-modified albumin (plasma) | 72 hours | ||
Secondary | Measurement of malondialdehyde (plasma) | 72 hours | ||
Secondary | Measurement of total antioxidant status (plasma) | 72 hours | ||
Secondary | Length of PICU stay - proportion of randomised patients with outcome available in each group | Through study completion, an average of 2 days | ||
Secondary | Length of PICU stay - mean (standard deviation) in each group. | Through study completion, an average of 2 days | ||
Secondary | Length of PICU stay - median and quartiles in each group. | Through study completion, an average of 2 days | ||
Secondary | Hospital mortality - proportion of randomised patients with outcome available in each group | Through study completion, an average of 2 days | ||
Secondary | Hospital mortality - number (percentage) in each group. | Through study completion, an average of 2 days | ||
Secondary | PICU mortality - proportion of randomised patients with outcome available in each group | Through study completion, an average of 2 days | ||
Secondary | PICU mortality - number (percentage) in each group. | Through study completion, an average of 2 days | ||
Secondary | Days of organ specific support - proportion of randomised patients with outcome available in each group | Through study completion, an average of 2 days | ||
Secondary | Days of organ specific support - mean (standard deviation) in each group | Through study completion, an average of 2 days | ||
Secondary | Days of organ specific support - median and quartiles in each group | Through study completion, an average of 2 days | ||
Secondary | Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes) | 72 hours |
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