Hyponatremia Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients in Rajavithi Hospital - Age from 18 years - Plasma Na < 125 mmol/l with glucose-corrected - Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence) Exclusion Criteria: - 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 - Patients with coronary artery disease - Patients with brain injuries - Deny consent |
Country | Name | City | State |
---|---|---|---|
Thailand | Rajavithi Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Rajavithi Hospital |
Thailand,
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Ayus 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. Review. — View Citation
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Garrahy 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: 10.1 — View Citation
George 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. — View Citation
Hoorn 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. Review. — View Citation
King JD, Rosner MH. Osmotic demyelination syndrome. Am J Med Sci. 2010 Jun;339(6):561-7. doi: 10.1097/MAJ.0b013e3181d3cd78. Review. — View Citation
Koenig 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. — View Citation
Lee 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 sym — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma sodium and glasglow coma scale(GCS) | Change in plasma sodium and level of consciousness (GCS) | 6 hours | |
Secondary | Plasma sodium and glasglow coma scale(GCS) | Change in plasma sodium and level of consciousness (GCS) | 24 and 48 hours | |
Secondary | 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 | 24 and 48 hours | |
Secondary | ODS rate | rate of osmotic demyelinating syndrome | in 7 days | |
Secondary | hospitality days | hospitality days | until discharge | |
Secondary | mortality rate | mortality rate | in 30 days |
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