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

This study has been completed.
Sponsor:
Collaborator:
Memorial Hermann Hospital
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01349218
First received: May 3, 2011
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Hyperkalemia
Other: Blood sample drawn from a vein
Other: Blood sample drawn from a heel stick

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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?

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Potassium Measurements [ Time Frame: 0-30 minutes after start of surgery ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 31
Study Start Date: March 2014
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood sample drawn from a vein and from a heel stick
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.
Other: Blood sample drawn from a vein
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.
Other: Blood sample drawn from a heel stick
A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01349218

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Memorial Hermann Hospital
Investigators
Principal Investigator: Samia N Khalil, M.D. Faculty
  More Information

Responsible Party: Samia Khalil, Professor - Anesthesiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01349218     History of Changes
Other Study ID Numbers: HSC-MS-10-0180 
Study First Received: May 3, 2011
Last Updated: May 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Potassium
Infants
Heel Stick
Less than or equal to 6 months of age
IV catheter blood samples
perioperatively
elective surgical procedures

Additional relevant MeSH terms:
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2016