HyponatremiaPhase 3surgical-NaNCT01251770
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
A Phase 3 study testing 0.45% NaCl/dextrose 5% and 0.3% NaCl/dextrose 5% in people with Hyponatremia, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
Trial summary
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Hyponatremia
- What is being tested?
- 0.45% NaCl/dextrose 5% and 0.3% NaCl/dextrose 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2010to Jul 2011
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.
- Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
- Informed consent of parent/guardian.
Who cannot join
- • Children with illness that have primary fluid and electrolyte imbalance such as:
- Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (<35oC), tachycardia, prolonged capillary filling time (>3 seconds), hypotension (BP < 5th percentile for age), oliguria (<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
- Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes \& dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
- Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.
- Hyperglycemia: blood glucose > 180 mg/ dl.
- Require ICU admission.
Show all 9Show fewer
- Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., C1270AAN
About this study
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
Read the detailed description
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday \& Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.
0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.
Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.
Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.
Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.
Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.
- Conditions
- Hyponatremia
- Being tested
- 0.45% NaCl/dextrose 5%, 0.3% NaCl/dextrose 5%
- Keywords
- Hyponatremia, Water-Electrolyte Imbalance
- Medical subject headings
- Hyponatremia, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.45% NaCl/dextrose 5%Drug
Also called half saline
Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface.
0.3% NaCl/dextrose 5%Drug
Also called third saline
Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface.
| Study group | Role | What they receive |
|---|---|---|
| half saline | Experimental | Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids. Receives: Drug: 0.45% NaCl/dextrose 5% |
| third saline | Active comparator | Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids. Receives: Drug: 0.3% NaCl/dextrose 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sodium Levels
Measured: Change from baseline in sodium level after 12 hours
Secondary outcomes (1)
IV Fluid Intake
Measured: 12 hours from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
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
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela Dicembrino, md, Principal investigator, Hospital de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251770
- Sponsor's protocol ID
- HGNPE-15-2010
- Acronym
- surgical-Na
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2010
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Choong 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 16754657Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.
PubMed 19818450Yung M, Keeley S. Randomised controlled trial of intravenous maintenance fluids. J Paediatr Child Health. 2009 Jan-Feb;45(1-2):9-14. doi: 10.1111/j.1440-1754.2007.01254.x. Epub 2007 Nov 25.
PubMed 18036144
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
- ClinicalTrials.gov ID
- NCT01251770
- Acronym / sponsor ID
- surgical-Na / HGNPE-15-2010
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia, Water-Electrolyte Imbalance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 25 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
Detailed description
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday \& Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.
0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.
Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.
Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.
Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.
Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| half saline | Experimental | Drug: 0.45% NaCl/dextrose 5%Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids. |
| third saline | Active comparator | Drug: 0.3% NaCl/dextrose 5%Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.
- Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
- Informed consent of parent/guardian.
Key exclusion criteria (9 listed)
- • Children with illness that have primary fluid and electrolyte imbalance such as:
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 |
|---|---|---|
| 0.45% NaCl/dextrose 5%Also: half salineSubjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface. | Drug | half saline |
| 0.3% NaCl/dextrose 5%Also: third salineDrug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface. | Drug | third saline |
Primary outcome
Change in Sodium Levels
Time frame: Change from baseline in sodium level after 12 hours
1 secondary outcome
IV Fluid Intake
Time frame: 12 hours from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 19818450Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.
- Background: PubMed 18036144Yung M, Keeley S. Randomised controlled trial of intravenous maintenance fluids. J Paediatr Child Health. 2009 Jan-Feb;45(1-2):9-14. doi: 10.1111/j.1440-1754.2007.01254.x. Epub 2007 Nov 25.
- Hyponatremia treatment guidelines 2007: expert panel recommendationsLink provided by the sponsor.
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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.
Manuela Dicembrino, md principal investigator
Hospital de Niños Pedro de Elizalde
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 0.45% NaCl/dextrose 5% and 0.3% NaCl/dextrose 5% in people with Hyponatremia, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
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 9 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 3 Mar 2017. 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 Argentina. 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 25 Jan 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?
Change in Sodium Levels (time frame: Change from baseline in sodium level after 12 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 NCT01251770, 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 3 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.