- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888431
Correlation of Arterial and Venous Lactate and Base Deficit Values
January 30, 2017 updated by: Joseph D. Tobias
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients requiring arterial access and peripheral access.
Additionally, patients with a central venous catheter would be included.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Arterial blood sample
0.5 mL blood sample from arterial line which is clinically indicated
|
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
|
A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During surgery- approximately 15-20 minutes after induction in the operating room (OR)
|
|
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.
|
During surgery- approximately 15-20 minutes after induction in the operating room (OR)
|
|
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.
|
During surgery- approximately 15-20 minutes after induction in the operating room (OR)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Tobias, Nationwide Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 17, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 5, 2016
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- IRB15-00793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Central Venous Catheter
-
Fenerbahce UniversityAcibadem Maslak HospitalNot yet recruitingPediatric Cancer | Pediatric Oncology | Central Venous Catheter | Central Venous Catheter Placement | Central Venous Catheter Exit Site InfectionTurkey (Türkiye)
-
Deutsche Interdisziplinäre Vereinigung für Intensiv-...Not yet recruitingCentral Venous CatheterGermany
-
Asklepios Neurological Clinic Bad SalzhausenKerckhoff KlinikCompleted
-
Soroka University Medical CenterUnknownCentral Venous CatheterIsrael
-
B. Braun Melsungen AGCompletedCentral Venous CatheterGermany, Italy
-
University Tunis El ManarCompleted
-
University of ParmaUnknownCentral Venous CatheterItaly
-
Interrad MedicalCompletedCentral Venous CatheterUnited States
-
University Tunis El ManarCompletedCentral Venous CatheterTunisia
-
Hospital Nossa Senhora da ConceicaoNot yet recruitingCatheter Complications | Catheter Related Complication | Central Venous Catheters
Clinical Trials on bedside point-of-care device
-
Temple UniversityCompleted
-
Obafemi Awolowo University Teaching HospitalMemorial Sloan Kettering Cancer CenterCompletedColorectal CancerNigeria
-
Kettering Health NetworkBilimetrix s.r.l.CompletedKernicterus | Point-of-Care Testing | Neonatal Screening | Newborn JaundiceUnited States
-
Slagelse HospitalZealand University Hospital; Copenhagen University Hospital at HerlevRecruitingPoint of Care Ultrasound (POCUS) | Emergency Laparotomies | Surgical Site Infection (SSI)Denmark
-
Wayne State UniversityMespere Lifesciences Inc.Completed
-
Yale UniversityKaren A. Santucci; M. Douglas Baker; i-Stat CorporationCompletedHyperglycemia | Gastroenteritis | Dehydration | Seizure
-
University of Maryland, BaltimoreDexCom, Inc.CompletedDiabetes MellitusUnited States
-
MRC/UVRI and LSHTM Uganda Research UnitKarolinska Institutet; Amsterdam Institute for Global Health and Development; University of Rwanda and other collaboratorsCompletedHIV | Viral Load | Point of Care MonitoringKenya, Tanzania, Rwanda, Uganda
-
University of Modena and Reggio EmiliaRecruitingOligohydramnios | Polyhydramnios | Small for Gestational Age Infant | Large for Gestational Age InfantItaly
-
University of South WalesRecruitingDeep Vein ThrombosisUnited Kingdom