HyponatremiaPhase 3NCT00734214
Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
A Phase 3 study testing 0.9% NaCl and 0.45%NaCl in people with Hyponatremia and Hypernatremia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. Read more about this study
- Who is it for?
- Ages 6 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyponatremia, Hypernatremia
- What is being tested?
- 0.9% NaCl and 0.45%NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Dec 2009
- 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 6 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients, 6 months corrected age -16 years, undergoing surgery.
- Within 6 hours of the immediate post-operative period.
- Post-operative stay anticipated to be more than 24 hours.
- Primary route of fluid administration is anticipated to be intravenous, in the first 24 hours following surgery.
- Informed consent of parent/guardian.
- Consent to participate from surgeon.
Who cannot join
- Patients under 6 months of age
- Patients equal to or over 17 years of age
- Patients with hemodynamic instability , defined as a requirement for continuous vasoactive infusion (e.g. epinephrine, dopamine, norepinephrine, phenylephrine, milrinone, or Dobutamine) to maintain blood pressure at the end of surgery.
- Patients admitted into the "short stay" post-operative unit
- Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
- Patients with known pre-existing risk of PNa derangements: DI or SIADH
Show all 10Show fewer
- Chronic diuretic use - defined as use of any oral or intravenous diuretics for ≥ 7 days.
- Known, uncorrected PNa derangement (PNa < 134 or > 146 mmol/L), identified peri-operatively (i.e. within 12 hours of surgery or during surgery).
- Prior enrolment in this study
- Patients or their guardians objecting to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypotonic Versus Isotonic Parenteral Fluids in Children - a Randomized Controlled Trial
Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. There is ongoing concern from the medical community that this type of fluid increases the child's risk of developing low sodium levels, and hence may not be safe for all children. Low sodium can lead to significant complications such as seizures, coma and even death, risks of which are often underestimated and not anticipated by their caregivers. Experts in the field suggest that giving a solution with a similar sodium content to that of blood (isotonic fluid) reduces the risk of these problems in these children. This study will compare these two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e. neither the patient nor caregivers or investigators will be aware which type of fluid the patient is receiving), in children following surgery. The investigators goal is to see which type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a lower risk of complications as described above.
This is the first time such a study is preformed in pediatrics. There are unnecessary number of complications and potential deaths from this disorder, and hence the safety of everyday fluid practice in children needs to be scientifically tested. The results of this study will enable the investigators to propose scientifically based guidelines on how to minimize risks associated with intravenous infusions in children.
Read the detailed description
Research Question:
In general pediatric surgical patients, do isotonic PMS compared to hypotonic PMS, result in a lower risk of acute hospital acquired plasma sodium derangements, occurring at any time during the study intervention? Primary efficacy objective -To determine the impact of postoperative administration of isotonic compared to hypotonic PMS on the risk of hospital acquired PNa derangements in pediatric surgical patients, occurring at any time during the study intervention.
Secondary efficacy objectives: a) To determine the impact of postoperative administration of isotonic compared to hypotonic PMS on clinical sequelae related to acute PNa changes, in pediatric surgical patients. b) the independent predictors of hospital acquired PNa derangements will be explored.
Study Design:
This is a double-blind randomized controlled trial. Participants, health care providers, data collectors, and judicial assessors of outcomes will be blinded to the study intervention.
Setting: McMaster Children's Hospital.
Trial Intervention:
Enrolled patients will be randomized postoperatively to receive either one of the following parenteral maintenance solutions: 1) hypotonic PMS, or 2) isotonic PMS. For the purposes of this study the hypotonic PMS will be 0.45%NaCl, and the Isotonic PMS will be 0.9% NaCl. Enrolled patients will receive their allocated treatment (provided there are no safety issues or concerns) until they are fully orally fed and the PMS rate is no greater than a rate required to "keep vein open (KVO)", to a maximum duration of 48 hours. The physician can thereafter administer the maintenance solution of their choice. The following parameters will be monitored in each study participant during the treatment period: hourly urine output, strict intake and output, 12 hourly fluid balances and daily weights. Blood and urine samples will be obtained on study patients every 12 hours until they are fully orally fed and the IV rate is at KVO, for a maximum of 48 hours. Any additional investigations ordered by the caring physician during the treatment and follow up period will also be recorded. Patients will be followed for clinical outcomes for 48 hours after the study intervention is discontinued, or until the time of discharge.
- Conditions
- Hyponatremia, Hypernatremia
- Being tested
- 0.9% NaCl, 0.45%NaCl
- Keywords
- Parenteral Fluids, Isotonic, Hypotonic, Pediatric, Fluid overload
- Medical subject headings
- Hyponatremia, Hypernatremia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% NaClDrug
Also called Isotonic saline
Intravenous Fluid
Isotonic Parenteral Fluid
0.45%NaClDrug
Also called Hypotonic saline
Intravenous Fluid
Hypotonic Parenteral Fluid
| Study group | Role | What they receive |
|---|---|---|
| 0.9% NaCl | Experimental | Not described Receives: Drug: 0.9% NaCl |
| 0.45% NaCl | Active comparator | Not described Receives: Drug: 0.45%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)
Measured: During the treatment and follow-up period.
Hyponatremia
Plasma sodium less than 135 mmol/L
Measured: during the study intervention
Secondary outcomes (1)
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.
Measured: During the treatment and follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
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 (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Choong, MB, BCh, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734214
- Sponsor's protocol ID
- 07-265
- Status last verified
- Apr 2015
- First submitted
- 12 Aug 2008
- Last updated
- 29 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Choong K, Arora S, Cheng J, Farrokhyar F, Reddy D, Thabane L, Walton JM. Hypotonic versus isotonic maintenance fluids after surgery for children: a randomized controlled trial. Pediatrics. 2011 Nov;128(5):857-66. doi: 10.1542/peds.2011-0415. Epub 2011 Oct 17.
PubMed 22007013
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotonic Versus Isotonic Parenteral Fluids in Children - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00734214
- Acronym / sponsor ID
- 07-265
- Conditions
- Hyponatremia, Hypernatremia
- Keywords
- Parenteral Fluids, Isotonic, Hypotonic, Pediatric, Fluid overload
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 13 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. There is ongoing concern from the medical community that this type of fluid increases the child's risk of developing low sodium levels, and hence may not be safe for all children. Low sodium can lead to significant complications such as seizures, coma and even death, risks of which are often underestimated and not anticipated by their caregivers. Experts in the field suggest that giving a solution with a similar sodium content to that of blood (isotonic fluid) reduces the risk of these problems in these children. This study will compare these two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e. neither the patient nor caregivers or investigators will be aware which type of fluid the patient is receiving), in children following surgery. The investigators goal is to see which type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a lower risk of complications as described above.
This is the first time such a study is preformed in pediatrics. There are unnecessary number of complications and potential deaths from this disorder, and hence the safety of everyday fluid practice in children needs to be scientifically tested. The results of this study will enable the investigators to propose scientifically based guidelines on how to minimize risks associated with intravenous infusions in children.
Detailed description
Research Question:
In general pediatric surgical patients, do isotonic PMS compared to hypotonic PMS, result in a lower risk of acute hospital acquired plasma sodium derangements, occurring at any time during the study intervention? Primary efficacy objective -To determine the impact of postoperative administration of isotonic compared to hypotonic PMS on the risk of hospital acquired PNa derangements in pediatric surgical patients, occurring at any time during the study intervention.
Secondary efficacy objectives: a) To determine the impact of postoperative administration of isotonic compared to hypotonic PMS on clinical sequelae related to acute PNa changes, in pediatric surgical patients. b) the independent predictors of hospital acquired PNa derangements will be explored.
Study Design:
This is a double-blind randomized controlled trial. Participants, health care providers, data collectors, and judicial assessors of outcomes will be blinded to the study intervention.
Setting: McMaster Children's Hospital.
Trial Intervention:
Enrolled patients will be randomized postoperatively to receive either one of the following parenteral maintenance solutions: 1) hypotonic PMS, or 2) isotonic PMS. For the purposes of this study the hypotonic PMS will be 0.45%NaCl, and the Isotonic PMS will be 0.9% NaCl. Enrolled patients will receive their allocated treatment (provided there are no safety issues or concerns) until they are fully orally fed and the PMS rate is no greater than a rate required to "keep vein open (KVO)", to a maximum duration of 48 hours. The physician can thereafter administer the maintenance solution of their choice. The following parameters will be monitored in each study participant during the treatment period: hourly urine output, strict intake and output, 12 hourly fluid balances and daily weights. Blood and urine samples will be obtained on study patients every 12 hours until they are fully orally fed and the IV rate is at KVO, for a maximum of 48 hours. Any additional investigations ordered by the caring physician during the treatment and follow up period will also be recorded. Patients will be followed for clinical outcomes for 48 hours after the study intervention is discontinued, or until the time of discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% NaCl | Experimental | Drug: 0.9% NaCl |
| 0.45% NaCl | Active comparator | Drug: 0.45%NaCl |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Pediatric patients, 6 months corrected age -16 years, undergoing surgery.
- Within 6 hours of the immediate post-operative period.
- Post-operative stay anticipated to be more than 24 hours.
- Primary route of fluid administration is anticipated to be intravenous, in the first 24 hours following surgery.
- Informed consent of parent/guardian.
Key exclusion criteria (10 listed)
- Patients under 6 months of age
- Patients equal to or over 17 years of age
- Patients with hemodynamic instability , defined as a requirement for continuous vasoactive infusion (e.g. epinephrine, dopamine, norepinephrine, phenylephrine, milrinone, or Dobutamine) to maintain blood pressure at the end of surgery.
- Patients admitted into the "short stay" post-operative unit
- Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
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% NaClAlso: Isotonic salineIntravenous Fluid Isotonic Parenteral Fluid | Drug | 0.9% NaCl |
| 0.45%NaClAlso: Hypotonic salineIntravenous Fluid Hypotonic Parenteral Fluid | Drug | 0.45% NaCl |
Primary outcome
Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)
Time frame: During the treatment and follow-up period.
Hyponatremia
Time frame: during the study intervention
Plasma sodium less than 135 mmol/L
1 secondary outcome
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.
Time frame: During the treatment and follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22007013Choong K, Arora S, Cheng J, Farrokhyar F, Reddy D, Thabane L, Walton JM. Hypotonic versus isotonic maintenance fluids after surgery for children: a randomized controlled trial. Pediatrics. 2011 Nov;128(5):857-66. doi: 10.1542/peds.2011-0415. Epub 2011 Oct 17.
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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.
Karen Choong, MB, BCh, MSc principal investigator
McMaster University
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% NaCl and 0.45%NaCl in people with Hyponatremia and Hypernatremia, run by Hamilton Health Sciences Corporation 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 6 inclusion and 10 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 29 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2012). 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 Acute Plasma Sodium Derangements (Hypo- or Hypernatremia) (time frame: During the treatment and follow-up period.). The study lists 2 primary outcomes in all. 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 NCT00734214, 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 29 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.