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Conservative Versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU)

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ClinicalTrials.gov Identifier: NCT03040570
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Intensive Care National Audit & Research Centre
University of Southampton
St Mary's Hospital, London
University Hospital Southampton NHS Foundation Trust
University College, London
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 23, 2018
Actual Study Start Date  ICMJE March 4, 2017
Actual Primary Completion Date June 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
Number of eligible patients recruited per site per month [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Proportion of parents/legal representatives refusing deferred consent [ Time Frame: Through study completion, an average of 24 hours ]
  • Proportion of eligible patients randomised [ Time Frame: Baseline ]
  • Distribution of time to randomisation [ Time Frame: Baseline ]
  • Proportion of systemic oxygen saturations within the target range in each group [ Time Frame: Through study completion, an average of 72 hours ]
  • Proportion of patients in each arm requiring other treatments influencing tissue oxygen delivery (blood transfusion, inotropic support) [ Time Frame: Through study completion, an average of 72 hours ]
  • Length of ventilation - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Length of ventilation - mean (standard deviation) in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Length of ventilation - median and quartiles in each group. [ Time Frame: Through study completion, an average of 2 days ]
  • Observed adverse events [ Time Frame: 28 days ]
  • Time taken for data collection and entry [ Time Frame: 28 days ]
  • Measurement of ischemia-modified albumin (plasma) [ Time Frame: 72 hours ]
  • Measurement of malondialdehyde (plasma) [ Time Frame: 72 hours ]
  • Measurement of total antioxidant status (plasma) [ Time Frame: 72 hours ]
  • Length of PICU stay - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Length of PICU stay - mean (standard deviation) in each group. [ Time Frame: Through study completion, an average of 2 days ]
  • Length of PICU stay - median and quartiles in each group. [ Time Frame: Through study completion, an average of 2 days ]
  • Hospital mortality - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Hospital mortality - number (percentage) in each group. [ Time Frame: Through study completion, an average of 2 days ]
  • PICU mortality - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  • PICU mortality - number (percentage) in each group. [ Time Frame: Through study completion, an average of 2 days ]
  • Days of organ specific support - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Days of organ specific support - mean (standard deviation) in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Days of organ specific support - median and quartiles in each group [ Time Frame: Through study completion, an average of 2 days ]
  • Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes) [ Time Frame: 72 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Official Title  ICMJE A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Brief Summary 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.
Detailed Description

Around 19,000 critically ill children are admitted to paediatric intensive care units (PICU) each year in the UK. A large number of these children need breathing support, and this is usually provided through an invasive machine called a 'ventilator'. Clinicians make decisions for treatment based on how much oxygen their patient has in their blood (this is called oxygen saturation or oxygenation) and currently the amount of oxygen critically ill children need is not fully understood. This means that some clinicians use a lower oxygen saturation target, and others, a higher target. This may be problematic as research in neonates (babies) and adults has shown that oxygen saturation levels can influence a patient's chance of survival, how long they stay in hospital and healthcare costs.

Response to oxygen is different in babies, children and adults. This means that the results from the neonatal and adult research are unlikely to be valid or applicable in children due to age-related differences. Urgent high quality clinical evidence is therefore needed to inform on the best targets of oxygenation during critical illness in children.

As large clinical trials are expensive to conduct, it is important to demonstrate that a large-scale trial can be done and that the different components of a trial can all work together. Therefore, the Oxy-PICU study is a 'pilot randomised clinical trial' (a smaller version of the trial we would like to conduct) and will test the feasibility and safety of conducting a large scale trial comparing a restrictive oxygen saturation target (88-92%) with a more liberal oxygen saturation target (>94%). Oxy-PICU will also collect blood and urine samples to allow for in depth study of the biology of the different oxygenation targets.

The pilot trial will take place at three PICUs (two in London and one in Southampton) and aims to include between 115-125 eligible children over six months. Given the emergency nature of these children and the need to provide immediate care, informed consent will be sought after the children are entered into the study (this is known as deferred consent).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Care
  • Hypoxia
  • Pediatric ALL
Intervention  ICMJE
  • Procedure: Conservative oxygenation target
    Participants allocated to the conservative oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining 88-92% (inclusive).
  • Procedure: Liberal oxygenation target
    Participants allocated to the liberal oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining >94%.
Study Arms  ICMJE
  • Experimental: Conservative oxygenation target
    Children in the conservative oxygenation target group receive treatment targeting oxygen saturation values of 88-92%.
    Intervention: Procedure: Conservative oxygenation target
  • Active Comparator: Liberal oxygenation target
    Children in the liberal oxygenation target group receive treatment targeting oxygen saturation values of >94%.
    Intervention: Procedure: Liberal oxygenation target
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2017
Actual Primary Completion Date June 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 39 Weeks to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040570
Other Study ID Numbers  ICMJE 15IA35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Great Ormond Street Hospital for Children NHS Foundation Trust
Study Sponsor  ICMJE Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators  ICMJE
  • Intensive Care National Audit & Research Centre
  • University of Southampton
  • St Mary's Hospital, London
  • University Hospital Southampton NHS Foundation Trust
  • University College, London
Investigators  ICMJE Not Provided
PRS Account Great Ormond Street Hospital for Children NHS Foundation Trust
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP