GastroenteritisPhase 3NCT00457873
Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy
A Phase 3 study testing 0.9% saline in 5% dextrose (intravenous) and 0.45% saline in 5% dextrose (intravenous) in people with Gastroenteritis and Bronchiolitis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Gastroenteritis, Bronchiolitis, Sepsis
- What is being tested?
- 0.9% saline in 5% dextrose (intravenous) and 0.45% saline in 5% dextrose (intravenous)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Apr 2008
- Phase
- Phase 3
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1 month to 18 years of age
- Require IV fluids for at least 8 hr.
- Baseline serum sodium >=136 mmol/L \& <=145 mmol/L
Who cannot join
- Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L
- Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
- Acute neurological illness such as meningitis or encephalitis
- Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:
Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.
Read more
Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.
Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.
- Conditions
- Gastroenteritis, Bronchiolitis, Sepsis, Urinary Tract Infection
- Being tested
- 0.9% saline in 5% dextrose (intravenous), 0.45% saline in 5% dextrose (intravenous)
- Keywords
- surgery
- Medical subject headings
- Gastroenteritis, Bronchiolitis, Sepsis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% saline in 5% dextrose (intravenous)Drug
Also called isotonic saline
0.45% saline in 5% dextrose (intravenous)Drug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 0.9% saline in 5% dextrose (intravenous) Receives: Drug: 0.9% saline in 5% dextrose (intravenous) |
| B | Active comparator | 0.45% saline in 5% dextrose (intravenous) Receives: Drug: 0.45% saline in 5% dextrose (intravenous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of change in serum sodium
Measured: 8 to 20 hours
Secondary outcomes (2)
hypertension
Measured: 8 to 20 hours
congestive heart failure
Measured: 8 to 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethany Foster, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bethany J Foster, MD, MSCE, Principal investigator, Montreal Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457873
- Sponsor's protocol ID
- PED-06-016
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2007
- Last updated
- 12 Apr 2022
- Results posted
- No
Publications
Hoorn EJ, Geary D, Robb M, Halperin ML, Bohn D. Acute hyponatremia related to intravenous fluid administration in hospitalized children: an observational study. Pediatrics. 2004 May;113(5):1279-84. doi: 10.1542/peds.113.5.1279.
PubMed 15121942Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227.
PubMed 12563043Neville KA, Verge CF, Rosenberg AR, O'Meara MW, Walker JL. Isotonic is better than hypotonic saline for intravenous rehydration of children with gastroenteritis: a prospective randomised study. Arch Dis Child. 2006 Mar;91(3):226-32. doi: 10.1136/adc.2005.084103. Epub 2005 Dec 13.
PubMed 16352625Saba TG, Fairbairn J, Houghton F, Laforte D, Foster BJ. A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatr. 2011 Sep 23;11:82. doi: 10.1186/1471-2431-11-82.
PubMed 21943218
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT00457873
- Acronym / sponsor ID
- PED-06-016
- Conditions
- Gastroenteritis, Bronchiolitis, Sepsis, Urinary Tract Infection
- Keywords
- surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 9 Apr 2007 (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.
Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:
Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.
Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.
Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 0.9% saline in 5% dextrose (intravenous)0.9% saline in 5% dextrose (intravenous) |
| B | Active comparator | Drug: 0.45% saline in 5% dextrose (intravenous)0.45% saline in 5% dextrose (intravenous) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1 month to 18 years of age
- Require IV fluids for at least 8 hr.
- Baseline serum sodium >=136 mmol/L \& <=145 mmol/L
Key exclusion criteria (4 listed)
- Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L
- Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
- Acute neurological illness such as meningitis or encephalitis
- Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)
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 |
|---|---|---|
| 0.9% saline in 5% dextrose (intravenous)Also: isotonic saline | Drug | A |
| 0.45% saline in 5% dextrose (intravenous) | Drug | B |
Primary outcome
rate of change in serum sodium
Time frame: 8 to 20 hours
2 secondary outcomes
hypertension
Time frame: 8 to 20 hours
congestive heart failure
Time frame: 8 to 20 hours
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 12 Apr 2022.
- Results publication: PubMed 15121942Hoorn EJ, Geary D, Robb M, Halperin ML, Bohn D. Acute hyponatremia related to intravenous fluid administration in hospitalized children: an observational study. Pediatrics. 2004 May;113(5):1279-84. doi: 10.1542/peds.113.5.1279.
- Results publication: PubMed 12563043Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227.
- Results publication: PubMed 16352625Neville KA, Verge CF, Rosenberg AR, O'Meara MW, Walker JL. Isotonic is better than hypotonic saline for intravenous rehydration of children with gastroenteritis: a prospective randomised study. Arch Dis Child. 2006 Mar;91(3):226-32. doi: 10.1136/adc.2005.084103. Epub 2005 Dec 13.
- Derived from this study: PubMed 21943218Saba TG, Fairbairn J, Houghton F, Laforte D, Foster BJ. A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatr. 2011 Sep 23;11:82. doi: 10.1186/1471-2431-11-82.
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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.
Bethany J Foster, MD, MSCE principal investigator
Montreal Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.9% saline in 5% dextrose (intravenous) and 0.45% saline in 5% dextrose (intravenous) in people with Gastroenteritis and Bronchiolitis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 4 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 12 Apr 2022. 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 Canada. 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 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?
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?
rate of change in serum sodium (time frame: 8 to 20 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 NCT00457873, which also lists 4 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 12 Apr 2022.