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Correlation of Arterial and Venous Lactate and Base Deficit Values

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ClinicalTrials.gov Identifier: NCT02888431
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:
The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.

Condition or disease Intervention/treatment
Arterial Access Peripheral Access Central Venous Catheter Device: bedside point-of-care device

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
Arterial blood sample
0.5 mL blood sample from arterial line which is clinically indicated
Device: bedside point-of-care device
A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.

peripheral venous blood sample
0.5 mL blood sample drawn simultaneously with arterial sample from clinically indicated peripheral line
Device: bedside point-of-care device
A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.




Primary Outcome Measures :
  1. lactate blood value [ Time Frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR) ]
    blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the lactate value will be assessed by using a bedside point-of-care device, called i-stat.

  2. base deficit blood value [ Time Frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR) ]
    blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the base deficit blood value will be assessed by using a bedside point-of-care device, called i-stat.

  3. pH blood value [ Time Frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR) ]
    blood will be drawn from peripheral venous line, arterial line, and/or central venous line then pH blood value will be assessed by using a bedside point-of-care device, called i-stat.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.
Criteria

Inclusion Criteria:

  • Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.

Exclusion Criteria:

  • Patients who not require arterial access.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888431


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
Investigators
Principal Investigator: Joseph Tobias Nationwide Children's Hospital

Responsible Party: Joseph D. Tobias, Chairman, Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02888431     History of Changes
Other Study ID Numbers: IRB15-00793
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Joseph D. Tobias, Nationwide Children's Hospital:
pH
base deficit
lactate values
venous blood samples
arterial blood samples