A Phase 3 interventional study of 0.9% NaCl and 0.45%NaCl in Hyponatremia and Hypernatremia, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 6 Months to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by Hamilton Health Sciences Corporation · Phase 3, Interventional, and Prevention
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.
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.
164 studies on the registry are indexed under Hyponatremia; 16 are open to participants now.
This study's enrollment of 258 is above the median of 60 across 98 interventional studies indexed under Hyponatremia.
Browse Hyponatremia studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 0.9% NaCl
Drug: 0.45%NaCl
Intravenous Fluid Isotonic Parenteral Fluid
Also known as: Isotonic saline
Intravenous Fluid Hypotonic Parenteral Fluid
Also known as: Hypotonic saline
Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)
Time frame: During the treatment and follow-up period.
Hyponatremia
Plasma sodium less than 135 mmol/L
Time frame: during the study intervention
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.
Time frame: During the treatment and follow-up period
| Milestone | 0.9% NaCl | 0.45% NaCl |
|---|---|---|
| Started | 128 | 130 |
| Completed | 124 | 126 |
| Not completed | 4 | 4 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Md withdrawal | 1 | 0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Plasma sodium less than 135 mmol/L
| participants | 0.9% NaCl | 0.45% NaCl |
|---|---|---|
| Hyponatremia | 29 | 53 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.9% NaCl | — | 0/128 (0%) | 9/128 (7%) |
| 0.45% NaCl | — | 0/130 (0%) | 8/130 (6.2%) |
| Event | 0.9% NaCl | 0.45% NaCl |
|---|---|---|
| Generalized edemaSkin and subcutaneous tissue disorders | 0/128 | 0/130 |
| New onset hypertensionBlood and lymphatic system disorders | 0/128 | 0/130 |
| Event | 0.9% NaCl | 0.45% NaCl |
|---|---|---|
| Generalized EdemaSkin and subcutaneous tissue disorders | 9/128 | 8/130 |
| New onset HypertensionBlood and lymphatic system disorders | 0/128 | 2/130 |
| Age, Categorical(Participants) | 0.9% NaCl | 0.45% NaCl | Total |
|---|---|---|---|
| <=18 years | 128 | 130 | 258 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 0.9% NaCl | 0.45% NaCl | Total |
|---|---|---|---|
| Mean | 9.2 ± 5.5 | 9.2 ± 5.7 | 9.2 ± 5.6 |
| Sex: Female, Male(Participants) | 0.9% NaCl | 0.45% NaCl | Total |
|---|---|---|---|
| Female | 75 | 68 | 143 |
| Male | 53 | 62 | 115 |
| Region of Enrollment(participants) | 0.9% NaCl | 0.45% NaCl | Total |
|---|---|---|---|
| Canada | 128 | 130 | 258 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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