Oxygen Consumption In Critically Ill Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Brian Kavanagh, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01521195
First received: January 18, 2012
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

The investigators propose to examine the relationship between DO2 and VO2 in critically ill patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can provide complete support of heart and lung function. In so doing, the investigators will be able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow through the ECMO circuit.

Null Hypothesis:

Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not associated with an increase in oxygen consumption.

Alternate Hypothesis:

Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is associated with an increase in oxygen consumption.


Condition Intervention Phase
Extracorporeal Membrane Oxygenation
Device: Extracorporeal blood flow via ECMO machine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study of the Relationship Between Oxygen Delivery and Consumption During Extracorporeal Membrane Oxygenation.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Oxygen consumption (VO2) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    VO2 will be measured using a mass spectrometer as this is the gold standard.

  • Oxygen consumption (VO2) [ Time Frame: 30min ] [ Designated as safety issue: No ]
    VO2 will be measured using a mass spectrometer as this is the gold standard.

  • Oxygen consumption (VO2) [ Time Frame: 60min ] [ Designated as safety issue: No ]
    VO2 will be measured using a mass spectrometer as this is the gold standard.

  • Oxygen consumption (VO2) [ Time Frame: 90min ] [ Designated as safety issue: No ]
    VO2 will be measured using a mass spectrometer as this is the gold standard.


Secondary Outcome Measures:
  • Arterial serum lactate level [ Time Frame: Baseline, 30min, 60min, 90min ] [ Designated as safety issue: No ]
  • Oxygen extraction ratio. [ Time Frame: Baseline, 30min, 60min, 90min ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients on veno-arterial (VA) ECMO Device: Extracorporeal blood flow via ECMO machine

Extracorporeal Membrane Oxygenation (ECMO) machine can provide complete support of heart and lung function.

Extracorporeal blood flow will be given at baseline rate, increased by 25% and decreased by 25%


  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in the Critical Care Unit on veno-arterial ECMO.
  • Hemodynamic stability established, as adjudged by the treating CCU staff physician.
  • Informed consent by parent or legal guardian.
  • Approval by treating CCU staff physician to approach parents/guardians for consent process at any given time.

Exclusion Criteria:

  • Patients in the Critical Care Unit on veno-venous (VV) ECMO.
  • Inability to tolerate study period without red cell transfusion.
  • Presence of a large leak around the endotracheal tube (> 10% tidal volume).
  • Patients requiring > 70 % FiO2 at the time of potential enrollment.
  • Parent or legal guardian refuse consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521195

Contacts
Contact: Vijay Anand, MD 416-813-6486 vijay.anand@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Principal Investigator: Brian Kavanagh, MD         
Sub-Investigator: Vijay Anand, MD         
Sub-Investigator: Andrew Redington, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Brian Kavanagh, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Brian Kavanagh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01521195     History of Changes
Other Study ID Numbers: 1000017147
Study First Received: January 18, 2012
Last Updated: August 15, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatric
ECMO
extracorporeal blood flow
VO2

ClinicalTrials.gov processed this record on August 20, 2014