HyponatremiaPhase 3NCT01909336
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
A Phase 3 study testing 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose and 0.9% Saline in 5% dextrose in people with Hyponatremia, run by Instituto Tecnologico y de Estudios Superiores de Monterey.
Trial summary
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions. Read more about this study
- Who is it for?
- Ages 3 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyponatremia
- What is being tested?
- 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose and 0.9% Saline in 5% dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 3 months to 15 years.
- Need for intravenous fluids for 8 hours or more.
- Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).
- Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).
- Acute gastrointestinal disorders (viral o bacterial gastroenteritis).
- Elective surgical procedures.
- Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal perforation, ileus).
Who cannot join
- Severe hyponatremia (serum sodium < 125 mEq/L).
- Severe hypernatremia (serum sodium >155 mEq/L).
- Need for intravenous fluids for less than 8 hours according with their treating physician.
- Severe dehydration or Shock.
- Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).
- Neurologic diseases.
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- Head trauma.
- Cerebral edema or Intracranial hypertension.
- Diabetic ketoacidosis.
- Use of diuretics one week or less before the study.
- Need for admission to the pediatric critical intensive care unit
About this study
Official title: Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
Read the detailed description
Multicenter, Randomized, Controlled clinical trial.
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions
This study will include 150 patients in 2 groups according to these type of pathology: group 1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and group 2: surgical conditions (pre, peri or postoperative patients will be included). Each group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In non-dehydrated patients the daily total volume of liquid infused will be determined by the volumetric Holliday- Segar* formula and the daily total volume will be calculated by adding the maintenance requirements (using the Holliday Segar formula) to the fluid deficit (according to percent of estimated weight**) in dehydrated patients.
The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%. The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24 hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the incidence of hyponatremia and the adverse clinical outcomes will be compared.
*0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; >20 kg: 1500 ml + 20ml/ kg over 20kg
** In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10% in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60 mL/kg) in moderate dehydration.
- Conditions
- Hyponatremia
- Being tested
- 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose, 0.9% Saline in 5% dextrose
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% Saline in 3.3% dextroseDrug
Also called Hypotonic Solutions: 0.3% Saline + 3.3% dextrose
Hypotonic Solutions: 0.3% Saline in 3.3% dextrose
0.45% Saline in 5% dextroseDrug
Also called Hypotonic Solutions: 0.45% Saline in 5% dextrose
Hypotonic Solutions: 0.45% Saline in 5% dextrose
0.9% Saline in 5% dextroseDrug
Also called Isotonic Solutions 0.9% Saline in 5% dextrose
Isotonic Solutions 0.9% Saline in 5% dextrose
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 0.3% Saline in 3.3% dextrose (intravenous) | Active comparator | Group 1: 0.3% Saline in 3.3% dextrose (intravenous) Receives: Drug: 0.3% Saline in 3.3% dextrose |
| Group 2: 0.45% Saline in 5% dextrose (intravenous) | Active comparator | Group 2: 0.45% Saline in 5% dextrose (intravenous) Receives: Drug: 0.45% Saline in 5% dextrose |
| Group 3: 0.9% Saline in 5% dextrose (intravenous) | Active comparator | Group 3: 0.9% Saline in 5% dextrose (intravenous) Receives: Drug: 0.9% Saline in 5% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Acquired Hyponatremia
Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study
Measured: 8 hours
Secondary outcomes (2)
Dysnatraemias at T8
hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)
Measured: 8 hours
Adverse Reactions Attributed to Acute Plasma Sodium Changes
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Collaborators
- Tecnologico de Monterrey
- Responsible party
- Principal investigator, Claudia Montserrat Flores Robles, MD, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Claudia Montserrat Flores Robles, MD, Principal investigator, Tecnologico de MonterreyCarlos Alberto Cuello García, MD, Study director, Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909336
- Sponsor's protocol ID
- SIvsSHnh
- Status last verified
- Oct 2016
- First submitted
- 14 Jul 2013
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.
PubMed 17592470Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5.
PubMed 16754657Montanana PA, Modesto i Alapont V, Ocon AP, Lopez PO, Lopez Prats JL, Toledo Parreno JD. The use of isotonic fluid as maintenance therapy prevents iatrogenic hyponatremia in pediatrics: a randomized, controlled open study. Pediatr Crit Care Med. 2008 Nov;9(6):589-97. doi: 10.1097/PCC.0b013e31818d3192.
PubMed 18838929
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.
- ClinicalTrials.gov ID
- NCT01909336
- Acronym / sponsor ID
- SIvsSHnh
- Conditions
- Hyponatremia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Collaborators
- Tecnologico de Monterrey
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Posted 16 Dec 2016
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 determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
Detailed description
Multicenter, Randomized, Controlled clinical trial.
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions
This study will include 150 patients in 2 groups according to these type of pathology: group 1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and group 2: surgical conditions (pre, peri or postoperative patients will be included). Each group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In non-dehydrated patients the daily total volume of liquid infused will be determined by the volumetric Holliday- Segar* formula and the daily total volume will be calculated by adding the maintenance requirements (using the Holliday Segar formula) to the fluid deficit (according to percent of estimated weight**) in dehydrated patients.
The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%. The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24 hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the incidence of hyponatremia and the adverse clinical outcomes will be compared.
*0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; >20 kg: 1500 ml + 20ml/ kg over 20kg
** In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10% in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60 mL/kg) in moderate dehydration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: 0.3% Saline in 3.3% dextrose (intravenous) | Active comparator | Drug: 0.3% Saline in 3.3% dextroseGroup 1: 0.3% Saline in 3.3% dextrose (intravenous) |
| Group 2: 0.45% Saline in 5% dextrose (intravenous) | Active comparator | Drug: 0.45% Saline in 5% dextroseGroup 2: 0.45% Saline in 5% dextrose (intravenous) |
| Group 3: 0.9% Saline in 5% dextrose (intravenous) | Active comparator | Drug: 0.9% Saline in 5% dextroseGroup 3: 0.9% Saline in 5% dextrose (intravenous) |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children between 3 months to 15 years.
- Need for intravenous fluids for 8 hours or more.
- Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).
- Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).
- Acute gastrointestinal disorders (viral o bacterial gastroenteritis).
Key exclusion criteria (11 listed)
- Severe hyponatremia (serum sodium < 125 mEq/L).
- Severe hypernatremia (serum sodium >155 mEq/L).
- Need for intravenous fluids for less than 8 hours according with their treating physician.
- Severe dehydration or Shock.
- Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).
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 |
|---|---|---|
| 0.3% Saline in 3.3% dextroseAlso: Hypotonic Solutions: 0.3% Saline + 3.3% dextroseHypotonic Solutions: 0.3% Saline in 3.3% dextrose | Drug | Group 1: 0.3% Saline in 3.3% dextrose (intravenous) |
| 0.45% Saline in 5% dextroseAlso: Hypotonic Solutions: 0.45% Saline in 5% dextroseHypotonic Solutions: 0.45% Saline in 5% dextrose | Drug | Group 2: 0.45% Saline in 5% dextrose (intravenous) |
| 0.9% Saline in 5% dextroseAlso: Isotonic Solutions 0.9% Saline in 5% dextroseIsotonic Solutions 0.9% Saline in 5% dextrose | Drug | Group 3: 0.9% Saline in 5% dextrose (intravenous) |
Primary outcome
Hospital Acquired Hyponatremia
Time frame: 8 hours
Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study
2 secondary outcomes
Dysnatraemias at T8
Time frame: 8 hours
Adverse Reactions Attributed to Acute Plasma Sodium Changes
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17592470Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.
- Background: PubMed 16754657Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5.
- Background: PubMed 18838929Montanana PA, Modesto i Alapont V, Ocon AP, Lopez PO, Lopez Prats JL, Toledo Parreno JD. The use of isotonic fluid as maintenance therapy prevents iatrogenic hyponatremia in pediatrics: a randomized, controlled open study. Pediatr Crit Care Med. 2008 Nov;9(6):589-97. doi: 10.1097/PCC.0b013e31818d3192.
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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.
Claudia Montserrat Flores Robles, MD principal investigator
Tecnologico de Monterrey
Carlos Alberto Cuello García, MD study director
Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose and 0.9% Saline in 5% dextrose in people with Hyponatremia, run by Instituto Tecnologico y de Estudios Superiores de Monterey.
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 7 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Acquired Hyponatremia (time frame: 8 hours). 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 NCT01909336, which also lists 3 linked publications.
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 16 Dec 2016.