An interventional study of Hypotonic Solution and Water Purified in Hypernatremia, sponsored by Hospital Civil de Guadalajara. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Hospital Civil de Guadalajara · Not applicable, Interventional, and Treatment
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units.
In this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous hypotonic solution compared to naso- or orogastric tube enteral water.
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units, increasing mortality. Currently, the most effective correction strategy for hypernatremia (intravenous hypotonic solution compared to enteral water) is still a matter of debate due to a lack of evidence and clinical trials.
This study aims to determine whether the administration of intravenous hypotonic solution is more effective in the correction of hypernatremia compared to enteral water by naso- or orogastric tube. Therefore, the investigator proposes the first randomized clinical trial, which compares two strategies used for the correction of hypernatremia, with this we will determine which of the two is more effective, and we will also compare the speed of correction, renal function during hospitalization with serum creatinine and we will evaluate its safety.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's planned enrollment of 178 is above the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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.
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.
In this group, the administration will be according to the presence of basal hyperglycemia on the day before the assignment (\>180mg/dL). If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily. If there is no hyperglycemia, it will be 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day.
Drug: Hypotonic Solution
This group will receive bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.
Drug: Water Purified
Intravenous administration of 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day. If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily.
administration of bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.
The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
Correction of hypernatremia is \<145mEq/L serum sodium
Time frame: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
mortality
Time frame: the first 5 days of the study
renal function
serum creatinine
Time frame: the first 5 days of the study
volume overload
volume overload determined by accumulated water balance in milliliters
Time frame: the first 5 days of the study
neurological alterations
neurological disorders defined as the presence of altered state of consciousness, seizures and/or cerebral edema
Time frame: the first 5 days of the study
hyperglycemia, glucose >180mg/dL
hyperglycemia defined as capillary glucose \>180mg/dL
Time frame: the first 5 days of the study
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Hospital Civil de Guadalajara