HypokalemiaPhase 4NCT02926989
Intravenous Fluids in Hospitalised Children
A Phase 4 study testing Plasmalyte Glucos 50 mg/mL and 0.45% saline in 5% dextrose in people with Hypokalemia and Hyponatremia, run by University of Oulu at 1 site in Finland.
Trial summary
The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypokalemia, Hyponatremia, Hypernatremia
- What is being tested?
- Plasmalyte Glucos 50 mg/mL and 0.45% saline in 5% dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteFinland
- Study dates
- 3 Oct 2016to 15 Apr 2019
- Phase
- Phase 4
- 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 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Acutely ill hospitalised children
- Need for intravenous fluid therapy
Who cannot join
- An initial plasma sodium concentration of lower than 130 mmol/L
- An initial plasma sodium concentration of higher than 150 mmol/L
- An initial plasma potassium concentration of lower than 3.0 mmol/L
- Need for 10% glucose solution
- Diabetes
- Diabetes insipidus
Show all 11Show fewer
- Diabetic ketoacidosis
- Renal disease that needs dialysis
- Protocol-determined chemotherapy hydration
- Severe liver disease
- Inborn errors of metabolism that need protocol-determined fluid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial
The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.
Read the detailed description
The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.
- Conditions
- Hypokalemia, Hyponatremia, Hypernatremia, Dehydration
- Being tested
- Plasmalyte Glucos 50 mg/mL, 0.45% saline in 5% dextrose
- Keywords
- Isotonic, Hypotonic, Intravenous fluids
- Medical subject headings
- Hypokalemia, Hyponatremia, Hypernatremia, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmalyte Glucos 50 mg/mLDrug
Also called ATC-code: B05BB02
Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
0.45% saline in 5% dextroseDrug
Also called 0.45% NaCl in 5% dextrose.
Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Isotonic solution | Experimental | Plasmalyte Glucos 50 mg/mL; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission. Receives: Drug: Plasmalyte Glucos 50 mg/mL |
| Hypotonic solution | Active comparator | 0.45% saline in 5% dextrose; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission. Receives: Drug: 0.45% saline in 5% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with a clinically significant electrolyte disorder
Plasma potassium concentration<3.5 mmol/L, or hypernatremia >148 mmol/L, or hyponatremia <132 mmol/L
Measured: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Secondary outcomes (14)
Proportion of children with hyponatremia
Plasma sodium concentration of lower than 132 mmol/L.
Measured: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hypernatremia
Plasma sodium concentration of higher than 148 mmol/L.
Measured: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hypokalemia
Potassium < 3.5 mmol/L
Measured: 0-7 days from study entry
Proportion of children with severe hypokalemia
Hypokalemia defined as concentration of potassium <3.0 mmol/L
Measured: 0-7 days from study entry
Fluid retention (g) measured by the weight change
Weight (g) at discharge - weight (g) at admission
Measured: 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Concentration of copeptin in plasma samples
Copeptin plasma concentration
Measured: 6-24 hours after study entry
Concentration of bicarbonate (HCO3) in plasma samples
Plasma concentration of bicarbonate HCO3
Measured: 1-3 days after study entry
Acidosis measured by pH in blood gas analysis
pH in the blood gas analysis
Measured: 1-3 days after study entry
Alkalosis measured by base excess (BE) in blood gas analysis
Base excess in the blood gas analysis
Measured: 1-3 days after study entry
Duration of intravenous fluid therapy
Hours from study entry to the stop of fluid therapy
Measured: From randomization up to seven days.
Proportion of children who needed change of the study fluid treatment
Any change of the fluid used in the treatment
Measured: From randomization up to seven days.
Proportion of children admitted to ICU
Admission to ICU for any reason
Measured: From randomization up to seven days.
Time to discharge from hospital in hours
Time from study entry to discharge in hours
Measured: From randomization up to seven days.
Number of deaths
Any death during the study
Measured: 0-30 days from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start3 Oct 2016
- Primary completion31 Mar 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypokalemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Terhi Tapiainen, University of Oulu
- Investigators
- Terhi Tapiainen, MD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926989
- Sponsor's protocol ID
- EETTMK 48/2016
- Status last verified
- Aug 2019
- First submitted
- 4 Oct 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lehtiranta S, Honkila M, Kallio M, Paalanne N, Peltoniemi O, Pokka T, Renko M, Tapiainen T. Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):28-35. doi: 10.1001/jamapediatrics.2020.3383.
PubMed 33104176
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02926989
- Acronym / sponsor ID
- EETTMK 48/2016
- Conditions
- Hypokalemia, Hyponatremia, Hypernatremia, Dehydration
- Keywords
- Isotonic, Hypotonic, Intravenous fluids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 6 Oct 2016 (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 main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.
Detailed description
The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic solution | Experimental | Drug: Plasmalyte Glucos 50 mg/mLPlasmalyte Glucos 50 mg/mL; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission. |
| Hypotonic solution | Active comparator | Drug: 0.45% saline in 5% dextrose0.45% saline in 5% dextrose; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Acutely ill hospitalised children
- Need for intravenous fluid therapy
Key exclusion criteria (11 listed)
- An initial plasma sodium concentration of lower than 130 mmol/L
- An initial plasma sodium concentration of higher than 150 mmol/L
- An initial plasma potassium concentration of lower than 3.0 mmol/L
- Need for 10% glucose solution
- Diabetes
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 |
|---|---|---|
| Plasmalyte Glucos 50 mg/mLAlso: ATC-code: B05BB02Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L. | Drug | Isotonic solution |
| 0.45% saline in 5% dextroseAlso: 0.45% NaCl in 5% dextrose.Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L. | Drug | Hypotonic solution |
Primary outcome
Proportion of children with a clinically significant electrolyte disorder
Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Plasma potassium concentration<3.5 mmol/L, or hypernatremia >148 mmol/L, or hyponatremia <132 mmol/L
14 secondary outcomes
Proportion of children with hyponatremia
Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hypernatremia
Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hypokalemia
Time frame: 0-7 days from study entry
Proportion of children with severe hypokalemia
Time frame: 0-7 days from study entry
Fluid retention (g) measured by the weight change
Time frame: 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Concentration of copeptin in plasma samples
Time frame: 6-24 hours after study entry
Concentration of bicarbonate (HCO3) in plasma samples
Time frame: 1-3 days after study entry
Acidosis measured by pH in blood gas analysis
Time frame: 1-3 days after study entry
Alkalosis measured by base excess (BE) in blood gas analysis
Time frame: 1-3 days after study entry
Duration of intravenous fluid therapy
Time frame: From randomization up to seven days.
Proportion of children who needed change of the study fluid treatment
Time frame: From randomization up to seven days.
Proportion of children admitted to ICU
Time frame: From randomization up to seven days.
Time to discharge from hospital in hours
Time frame: From randomization up to seven days.
Number of deaths
Time frame: 0-30 days from study entry
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 22 Aug 2019.
- Derived from this study: PubMed 33104176Lehtiranta S, Honkila M, Kallio M, Paalanne N, Peltoniemi O, Pokka T, Renko M, Tapiainen T. Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):28-35. doi: 10.1001/jamapediatrics.2020.3383.
- Individual participant dataSharing planned: No
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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.
Terhi Tapiainen, MD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasmalyte Glucos 50 mg/mL and 0.45% saline in 5% dextrose in people with Hypokalemia and Hyponatremia, run by University of Oulu at 1 site in Finland.
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 2 inclusion and 11 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 22 Aug 2019. 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 Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of children with a clinically significant electrolyte disorder (time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926989, which also lists 1 linked publication.
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 22 Aug 2019.