HyponatremiaNCT04561531
Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.
A study testing 3%NaCl in people with Hyponatremia and Osmotic Demyelination Syndrome, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Osmotic Demyelination Syndrome
- What is being tested?
- 3%NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 30 Sep 2020to 30 Sep 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in Rajavithi Hospital
- Age from 18 years
- Plasma Na < 125 mmol/l with glucose-corrected
- Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)
Who cannot join
- Systolic BP < 90 mmHg Or MAP< 70 mmHg
- Pregnancy or Lactation
- Congestive Heart Failure or Volume overload
- Lung congestionfrom CXR
- Chronic renal failure patients with edema
- Cirrhosis patients with edema
Show all 9Show fewer
- Patients with coronary artery disease
- Patients with brain injuries
- Deny consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital
To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.
Read the detailed description
Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions.
Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa<125mmol/L) in Rajavithi Hospital into two groups:
First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate.
- Conditions
- Hyponatremia, Osmotic Demyelination Syndrome
- Being tested
- 3%NaCl
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3%NaClOther
Intervention is infusion of 3%NaCl which is defined in arms of experiment.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent bolus | Experimental | In intermittent bolus of 3%NaCl group ,patients will receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and then follow plasma sodium,observe glasglow coma scale and level of consciousness until improvement of consciousness and achieve target plasma sodium which is 5 mmol/L in 6 hours and should not be overcorrected which defined that plasma sodium change should not be more than 12 mmol/L in 24 hours and 18 mmol/L in 48 hours. Receives: Other: 3%NaCl |
| Traditional continuous drip | Experimental | In traditional continuous drip of 3%NaCl group ,patients will receive 3%NaCl adjust rate start from 1 ml/kg/hr and follow plasma sodium every 1 hour,observe glasglow coma scale and level of consciousness until improvement of consciousness and achieve target plasma sodium which is 5 mmol/L in 6 hours and should not be overcorrected which defined that plasma sodium change should not be more than 12 mmol/L in 24 hours and 18 mmol/L in 48 hours. Receives: Other: 3%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma sodium and glasglow coma scale(GCS)
Change in plasma sodium and level of consciousness (GCS)
Measured: 6 hours
Secondary outcomes (5)
Plasma sodium and glasglow coma scale(GCS)
Change in plasma sodium and level of consciousness (GCS)
Measured: 24 and 48 hours
overcorrection rate
rate of overcorrection which defined as change in plasma sodium over 12 mmol/L in 24 hr and 18 mmol/L in 48 hr
Measured: 24 and 48 hours
ODS rate
rate of osmotic demyelinating syndrome
Measured: in 7 days
hospitality days
hospitality days
Measured: until discharge
mortality rate
mortality rate
Measured: in 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start30 Sep 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561531
- Sponsor's protocol ID
- 148/2563
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
King JD, Rosner MH. Osmotic demyelination syndrome. Am J Med Sci. 2010 Jun;339(6):561-7. doi: 10.1097/MAJ.0b013e3181d3cd78.
PubMed 20453633Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar.
PubMed 24569125Ayus JC, Krothapalli RK, Arieff AI. Treatment of symptomatic hyponatremia and its relation to brain damage. A prospective study. N Engl J Med. 1987 Nov 5;317(19):1190-5. doi: 10.1056/NEJM198711053171905.
PubMed 3309659Adrogue HJ, Madias NE. Hyponatremia. N Engl J Med. 2000 May 25;342(21):1581-9. doi: 10.1056/NEJM200005253422107. No abstract available.
PubMed 10824078Ball SG, Iqbal Z. Diagnosis and treatment of hyponatraemia. Best Pract Res Clin Endocrinol Metab. 2016 Mar;30(2):161-73. doi: 10.1016/j.beem.2015.12.001. Epub 2015 Dec 30.
PubMed 27156756Sterns RH, Nigwekar SU, Hix JK. The treatment of hyponatremia. Semin Nephrol. 2009 May;29(3):282-99. doi: 10.1016/j.semnephrol.2009.03.002.
PubMed 19523575Koenig MA, Bryan M, Lewin JL 3rd, Mirski MA, Geocadin RG, Stevens RD. Reversal of transtentorial herniation with hypertonic saline. Neurology. 2008 Mar 25;70(13):1023-9. doi: 10.1212/01.wnl.0000304042.05557.60. Epub 2008 Feb 13.
PubMed 18272864Hoorn EJ, Zietse R. Diagnosis and Treatment of Hyponatremia: Compilation of the Guidelines. J Am Soc Nephrol. 2017 May;28(5):1340-1349. doi: 10.1681/ASN.2016101139. Epub 2017 Feb 7.
PubMed 28174217Garrahy A, Dineen R, Hannon AM, Cuesta M, Tormey W, Sherlock M, Thompson CJ. Continuous Versus Bolus Infusion of Hypertonic Saline in the Treatment of Symptomatic Hyponatremia Caused by SIAD. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3595-3602. doi: 10.1210/jc.2019-00044.
PubMed 30882872George JC, Zafar W, Bucaloiu ID, Chang AR. Risk Factors and Outcomes of Rapid Correction of Severe Hyponatremia. Clin J Am Soc Nephrol. 2018 Jul 6;13(7):984-992. doi: 10.2215/CJN.13061117. Epub 2018 Jun 5.
PubMed 29871886Mohmand HK, Issa D, Ahmad Z, Cappuccio JD, Kouides RW, Sterns RH. Hypertonic saline for hyponatremia: risk of inadvertent overcorrection. Clin J Am Soc Nephrol. 2007 Nov;2(6):1110-7. doi: 10.2215/CJN.00910207. Epub 2007 Oct 3.
PubMed 17913972Owen BE, Rogers IR, Hoffman MD, Stuempfle KJ, Lewis D, Fogard K, Verbalis JG, Hew-Butler T. Efficacy of oral versus intravenous hypertonic saline in runners with hyponatremia. J Sci Med Sport. 2014 Sep;17(5):457-62. doi: 10.1016/j.jsams.2013.09.001. Epub 2013 Sep 18.
PubMed 24148616Lee A, Jo YH, Kim K, Ahn S, Oh YK, Lee H, Shin J, Chin HJ, Na KY, Lee JB, Baek SH, Kim S. Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial). Trials. 2017 Mar 29;18(1):147. doi: 10.1186/s13063-017-1865-z.
PubMed 28356136
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital
- ClinicalTrials.gov ID
- NCT04561531
- Acronym / sponsor ID
- 148/2563
- Conditions
- Hyponatremia, Osmotic Demyelination Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 23 Sep 2020 (actual)
- 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.
To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.
Detailed description
Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions.
Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa<125mmol/L) in Rajavithi Hospital into two groups:
First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent bolus | Experimental | Other: 3%NaClIn intermittent bolus of 3%NaCl group ,patients will receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and then follow plasma sodium,observe glasglow coma scale and level of consciousness until improvement of consciousness and achieve target plasma sodium which is 5 mmol/L in 6 hours and should not be overcorrected which defined that plasma sodium change should not be more than 12 mmol/L in 24 hours and 18 mmol/L in 48 hours. |
| Traditional continuous drip | Experimental | Other: 3%NaClIn traditional continuous drip of 3%NaCl group ,patients will receive 3%NaCl adjust rate start from 1 ml/kg/hr and follow plasma sodium every 1 hour,observe glasglow coma scale and level of consciousness until improvement of consciousness and achieve target plasma sodium which is 5 mmol/L in 6 hours and should not be overcorrected which defined that plasma sodium change should not be more than 12 mmol/L in 24 hours and 18 mmol/L in 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in Rajavithi Hospital
- Age from 18 years
- Plasma Na < 125 mmol/l with glucose-corrected
- Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)
Key exclusion criteria (9 listed)
- Systolic BP < 90 mmHg Or MAP< 70 mmHg
- Pregnancy or Lactation
- Congestive Heart Failure or Volume overload
- Lung congestionfrom CXR
- Chronic renal failure patients with edema
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 |
|---|---|---|
| 3%NaClIntervention is infusion of 3%NaCl which is defined in arms of experiment. | Other | Intermittent bolus, Traditional continuous drip |
Primary outcome
Plasma sodium and glasglow coma scale(GCS)
Time frame: 6 hours
Change in plasma sodium and level of consciousness (GCS)
5 secondary outcomes
Plasma sodium and glasglow coma scale(GCS)
Time frame: 24 and 48 hours
overcorrection rate
Time frame: 24 and 48 hours
ODS rate
Time frame: in 7 days
hospitality days
Time frame: until discharge
mortality rate
Time frame: in 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 20453633King JD, Rosner MH. Osmotic demyelination syndrome. Am J Med Sci. 2010 Jun;339(6):561-7. doi: 10.1097/MAJ.0b013e3181d3cd78.
- Results publication: PubMed 24569125Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar.
- Results publication: PubMed 3309659Ayus JC, Krothapalli RK, Arieff AI. Treatment of symptomatic hyponatremia and its relation to brain damage. A prospective study. N Engl J Med. 1987 Nov 5;317(19):1190-5. doi: 10.1056/NEJM198711053171905.
- Results publication: PubMed 10824078Adrogue HJ, Madias NE. Hyponatremia. N Engl J Med. 2000 May 25;342(21):1581-9. doi: 10.1056/NEJM200005253422107. No abstract available.
- Results publication: PubMed 27156756Ball SG, Iqbal Z. Diagnosis and treatment of hyponatraemia. Best Pract Res Clin Endocrinol Metab. 2016 Mar;30(2):161-73. doi: 10.1016/j.beem.2015.12.001. Epub 2015 Dec 30.
- Results publication: PubMed 19523575Sterns RH, Nigwekar SU, Hix JK. The treatment of hyponatremia. Semin Nephrol. 2009 May;29(3):282-99. doi: 10.1016/j.semnephrol.2009.03.002.
- Results publication: PubMed 18272864Koenig MA, Bryan M, Lewin JL 3rd, Mirski MA, Geocadin RG, Stevens RD. Reversal of transtentorial herniation with hypertonic saline. Neurology. 2008 Mar 25;70(13):1023-9. doi: 10.1212/01.wnl.0000304042.05557.60. Epub 2008 Feb 13.
- Results publication: PubMed 28174217Hoorn EJ, Zietse R. Diagnosis and Treatment of Hyponatremia: Compilation of the Guidelines. J Am Soc Nephrol. 2017 May;28(5):1340-1349. doi: 10.1681/ASN.2016101139. Epub 2017 Feb 7.
- Results publication: PubMed 30882872Garrahy A, Dineen R, Hannon AM, Cuesta M, Tormey W, Sherlock M, Thompson CJ. Continuous Versus Bolus Infusion of Hypertonic Saline in the Treatment of Symptomatic Hyponatremia Caused by SIAD. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3595-3602. doi: 10.1210/jc.2019-00044.
- Results publication: PubMed 29871886George JC, Zafar W, Bucaloiu ID, Chang AR. Risk Factors and Outcomes of Rapid Correction of Severe Hyponatremia. Clin J Am Soc Nephrol. 2018 Jul 6;13(7):984-992. doi: 10.2215/CJN.13061117. Epub 2018 Jun 5.
- Results publication: PubMed 17913972Mohmand HK, Issa D, Ahmad Z, Cappuccio JD, Kouides RW, Sterns RH. Hypertonic saline for hyponatremia: risk of inadvertent overcorrection. Clin J Am Soc Nephrol. 2007 Nov;2(6):1110-7. doi: 10.2215/CJN.00910207. Epub 2007 Oct 3.
- Results publication: PubMed 24148616Owen BE, Rogers IR, Hoffman MD, Stuempfle KJ, Lewis D, Fogard K, Verbalis JG, Hew-Butler T. Efficacy of oral versus intravenous hypertonic saline in runners with hyponatremia. J Sci Med Sport. 2014 Sep;17(5):457-62. doi: 10.1016/j.jsams.2013.09.001. Epub 2013 Sep 18.
- 7\. Mohamed OH, Abdallah N. Prevention and treatment of the osmotic demyelination syndrome: JSM Brain Sci 2016; 1: 1004.Link provided by the sponsor.
- 14\. Lambeck J, Hieber M, Dreßing A, Niesen WD. Central pontine myelinolysis and osmotic demyelination syndrome. Dtsch Arztebl Int. 2019; 116: 600-6.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3%NaCl in people with Hyponatremia and Osmotic Demyelination Syndrome, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orakan Lanwong (0803625252, orakanpor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma sodium and glasglow coma scale(GCS) (time frame: 6 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 NCT04561531, which also lists 13 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 25 Feb 2021.