HyponatremiaNaCrIChNCT01301274
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
A study testing hypotonic and isotonic 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 mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hyponatremia
- What is being tested?
- hypotonic and isotonic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteArgentina
- Study dates
- Feb 2011to Nov 2011
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 month to 18 years
- ICU stay >24 hours
- Normal seric sodium (135 - 145 mEq/L).
- Requirement of IV maintenance solutions >80% total fluids intake
Who cannot join
- Patients with diagnoses of renal failure (serum creatinine >1 g/dl in <3 years old children, >1,5 in >3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
- Diuretics use in the first 48 hours thereafter indicated IV solutions.
- Plasma glucose is >200 mg%.
- Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.
Read the detailed description
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.
However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.
It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.
More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.
It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.
There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.
- Conditions
- Hyponatremia
- Being tested
- hypotonic, isotonic
- Keywords
- hyponatremia, maintenance solutions, pediatrics
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotonicDrug
Also called half saline/5% dextrose
0.45% NaCl/5% dextrose IV maintenance fluids
isotonicDrug
Also called normal saline/5% dextrose
0.9% NaCl/5% dextrose IV maintenance fluids
| Study group | Role | What they receive |
|---|---|---|
| Hypotonic | Active comparator | Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. Receives: Drug: hypotonic |
| Isotonic | Experimental | Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. Receives: Drug: isotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Sodium Levels in Both Groups
Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion
Measured: first 48 hours
Secondary outcomes (3)
Mortality at 28 Days
Mortality in both groups will be compared 28 days after admission
Measured: 28 days after admission
Mechanical Ventilation Free Days at 28 Day of Admission
mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.
Measured: first 28 day after starting mechanical ventilation
ICU Length of Stay
ICU length of stay (in days)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 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 (5)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Facundo A Jorro, MD, Principal investigator, Hospital General de Niños Pedro de ElizaldeGustavo De Baisi, MD, Study director, Hospital General de Niños Pedro de ElizaldeSusana Bengoa, Principal investigator, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301274
- Sponsor's protocol ID
- HGNPE-20-2011
- Acronym
- NaCrICh
- Status last verified
- Mar 2012
- First submitted
- 18 Feb 2011
- Last updated
- 7 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
HOLLIDAY MA, SEGAR WE, LUKENBILL A, VALENCIA RM, DURELL AM. Variations in muscle electrolyte composition due to sampling and to aging. Proc Soc Exp Biol Med. 1957 Aug-Sep;95(4):786-8. doi: 10.3181/00379727-95-23364. No abstract available.
PubMed 13465804Burrows FA, Shutack JG, Crone RK. Inappropriate secretion of antidiuretic hormone in a postsurgical pediatric population. Crit Care Med. 1983 Jul;11(7):527-31. doi: 10.1097/00003246-198307000-00009.
PubMed 6861500Eulmesekian PG, Perez A, Minces PG, Bohn D. Hospital-acquired hyponatremia in postoperative pediatric patients: prospective observational study. Pediatr Crit Care Med. 2010 Jul;11(4):479-83. doi: 10.1097/PCC.0b013e3181ce7154.
PubMed 20124948Choong 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 16754657Jorro Baron FA, Meregalli CN, Rombola VA, Bolasell C, Pigliapoco VE, Bartoletti SE, Debaisi GE. Hypotonic versus isotonic maintenance fluids in critically ill pediatric patients: a randomized controlled trial. Arch Argent Pediatr. 2013 Jul-Aug;111(4):281-7. doi: 10.5546/aap.2013.eng.281. English, Spanish.
PubMed 23912284
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
- ClinicalTrials.gov ID
- NCT01301274
- Acronym / sponsor ID
- NaCrICh / HGNPE-20-2011
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, maintenance solutions, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Posted 7 Mar 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 mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.
Detailed description
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.
However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.
It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.
More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.
It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.
There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.
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 |
|---|---|---|
| Hypotonic | Active comparator | Drug: hypotonicSubjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. |
| Isotonic | Experimental | Drug: isotonicSubjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 1 month to 18 years
- ICU stay >24 hours
- Normal seric sodium (135 - 145 mEq/L).
- Requirement of IV maintenance solutions >80% total fluids intake
Key exclusion criteria (4 listed)
- Patients with diagnoses of renal failure (serum creatinine >1 g/dl in <3 years old children, >1,5 in >3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
- Diuretics use in the first 48 hours thereafter indicated IV solutions.
- Plasma glucose is >200 mg%.
- Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
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 |
|---|---|---|
| hypotonicAlso: half saline/5% dextrose0.45% NaCl/5% dextrose IV maintenance fluids | Drug | Hypotonic |
| isotonicAlso: normal saline/5% dextrose0.9% NaCl/5% dextrose IV maintenance fluids | Drug | Isotonic |
Primary outcome
Serum Sodium Levels in Both Groups
Time frame: first 48 hours
Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion
3 secondary outcomes
Mortality at 28 Days
Time frame: 28 days after admission
Mechanical Ventilation Free Days at 28 Day of Admission
Time frame: first 28 day after starting mechanical ventilation
ICU Length of Stay
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 13465804HOLLIDAY MA, SEGAR WE, LUKENBILL A, VALENCIA RM, DURELL AM. Variations in muscle electrolyte composition due to sampling and to aging. Proc Soc Exp Biol Med. 1957 Aug-Sep;95(4):786-8. doi: 10.3181/00379727-95-23364. No abstract available.
- Background: PubMed 6861500Burrows FA, Shutack JG, Crone RK. Inappropriate secretion of antidiuretic hormone in a postsurgical pediatric population. Crit Care Med. 1983 Jul;11(7):527-31. doi: 10.1097/00003246-198307000-00009.
- Background: PubMed 20124948Eulmesekian PG, Perez A, Minces PG, Bohn D. Hospital-acquired hyponatremia in postoperative pediatric patients: prospective observational study. Pediatr Crit Care Med. 2010 Jul;11(4):479-83. doi: 10.1097/PCC.0b013e3181ce7154.
- 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.
- Derived from this study: PubMed 23912284Jorro Baron FA, Meregalli CN, Rombola VA, Bolasell C, Pigliapoco VE, Bartoletti SE, Debaisi GE. Hypotonic versus isotonic maintenance fluids in critically ill pediatric patients: a randomized controlled trial. Arch Argent Pediatr. 2013 Jul-Aug;111(4):281-7. doi: 10.5546/aap.2013.eng.281. English, Spanish.
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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.
Facundo A Jorro, MD principal investigator
Hospital General de Niños Pedro de Elizalde
Gustavo De Baisi, MD study director
Hospital General de Niños Pedro de Elizalde
Susana Bengoa principal investigator
Hospital General 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 study testing hypotonic and isotonic 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 4 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 7 Mar 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 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?
Serum Sodium Levels in Both Groups (time frame: first 48 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 NCT01301274, which also lists 5 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 7 Mar 2012.