HyperkalemiaPSNCT01349218
Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns
A study testing Blood sample drawn from a vein and Blood sample drawn from a heel stick in people with Hyperkalemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Blood sample drawn from a vein and Blood sample drawn from a heel stick
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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.
- Conditions
- Hyperkalemia
- Being tested
- Blood sample drawn from a vein, Blood sample drawn from a heel stick
- Keywords
- Potassium, Infants, Heel Stick, Less than or equal to 6 months of age, IV catheter blood samples, perioperatively, elective surgical procedures
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample drawn from a veinOther
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.
Blood sample drawn from a heel stickOther
A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.
| Study group | Role | What they receive |
|---|---|---|
| Blood sample drawn from a vein and from a heel stick | Experimental | 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. Receives: Other: Blood sample drawn from a vein; Other: Blood sample drawn from a heel stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-30 minutes after start of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Responsible party
- Principal investigator, Samia Khalil, The University of Texas Health Science Center, Houston
- Investigators
- Samia N Khalil, M.D., Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349218
- Sponsor's protocol ID
- HSC-MS-10-0180
- Acronym
- PS
- Status last verified
- May 2016
- First submitted
- 3 May 2011
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01349218
- Acronym / sponsor ID
- PS / HSC-MS-10-0180
- Conditions
- Hyperkalemia
- Keywords
- Potassium, Infants, Heel Stick, Less than or equal to 6 months of age, IV catheter blood samples, perioperatively, elective surgical procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample drawn from a vein and from a heel stick | Experimental | Other: Blood sample drawn from a vein, Other: Blood sample drawn from a heel stick0.5 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample drawn from a vein0.5 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 vein and from a heel stick |
| Blood sample drawn from a heel stickA 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 and from a heel stick |
Primary outcome
Potassium Measurements
Time frame: 0-30 minutes after start of surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Related trials for Hyperkalemia
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Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
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Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
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Hyperkalemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samia N Khalil, M.D. principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample drawn from a vein and Blood sample drawn from a heel stick in people with Hyperkalemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potassium Measurements (time frame: 0-30 minutes after start of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.