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Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns (PS)

Primary Purpose

Hyperkalemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood sample drawn from a vein
Blood sample drawn from a heel stick
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hyperkalemia focused on measuring Potassium, Infants, Heel Stick, Less than or equal to 6 months of age, IV catheter blood samples, perioperatively, elective surgical procedures

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infants and babies, ASA physical Status I-III, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at Children's Memorial Hermann Hospital will be included.

Exclusion Criteria:

  • Babies and infants with documented anemia (< 8 gm), who are bleeding, ASA Classification >III, have sickle cell disease or trait, thalassemia, HIV or DIC will be excluded from the study. Babies with organ failure will be excluded.

Sites / Locations

  • Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood sample drawn from a vein and from a heel stick

Arm Description

0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.

Outcomes

Primary Outcome Measures

Potassium Measurements
In this prospective study, we would like to evaluate whether there is a correlation between the potassium level in blood samples drawn from a vein and those drawn from a heel stick.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2011
Last Updated
May 12, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01349218
Brief Title
Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns
Acronym
PS
Official Title
In Infants and Newborns, is There a Relation Between the Potassium Level in Blood Samples Drawn From a Vein and Those Drawn From a Heel Stick?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out whether there is a correlation (link) between the level of potassium in blood samples drawn from a vein and those drawn from a heel stick in infants scheduled for elective surgery.
Detailed Description
This is a prospective study which will take place at the Children's Memorial Hermann Hospital Operating Room. After obtaining written informed consent from parents or guardians, infants and babies scheduled to have elective surgery under routine general anesthesia and are <6 months of age will be included in the study. After the baby receives routine general anesthesia, a small amount of blood, 0.5 ml, will be drawn from a vein when an I.V. is started for the surgery. The largest possible cannula will be placed whenever possible to decrease hemolysis. If a baby has a central line, the blood sample will be drawn from it. If a baby has an existing peripheral I.V., a blood sample will be drawn from the I.V. cannula only if blood is freely running, to avoid hemolysis. Blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml, will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis. The heel will be properly sterilized, and a proper size lancet will be used. The same operator will be performing the heel stick in each case.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia
Keywords
Potassium, Infants, Heel Stick, Less than or equal to 6 months of age, IV catheter blood samples, perioperatively, elective surgical procedures

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood sample drawn from a vein and from a heel stick
Arm Type
Experimental
Arm Description
0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.
Intervention Type
Other
Intervention Name(s)
Blood sample drawn from a vein
Intervention Description
0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis.
Intervention Type
Other
Intervention Name(s)
Blood sample drawn from a heel stick
Intervention Description
A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.
Primary Outcome Measure Information:
Title
Potassium Measurements
Description
In this prospective study, we would like to evaluate whether there is a correlation between the potassium level in blood samples drawn from a vein and those drawn from a heel stick.
Time Frame
0-30 minutes after start of surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants and babies, ASA physical Status I-III, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at Children's Memorial Hermann Hospital will be included. Exclusion Criteria: Babies and infants with documented anemia (< 8 gm), who are bleeding, ASA Classification >III, have sickle cell disease or trait, thalassemia, HIV or DIC will be excluded from the study. Babies with organ failure will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia N Khalil, M.D.
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns

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