Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

NCT06061783 | Unknown DMC

• 1 other identifier: Correction of hypernatremia
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypernatremia

Keywords

Hypernatremia; intravenous hypotonic solution; enteral water

Outcome Measures

Primary Outcomes (1)

• The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.

  Correction of hypernatremia is \<145mEq/L serum sodium

  every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.

Secondary Outcomes (4)

• mortality

  the first 5 days of the study

• renal function

  the first 5 days of the study

• volume overload

  the first 5 days of the study

• neurological alterations

  the first 5 days of the study

Other Outcomes (1)

• hyperglycemia, glucose >180mg/dL

  the first 5 days of the study

Study Arms (2)

Intravenous hypotonic solution

ACTIVE COMPARATOR

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

Enteral water

PLACEBO COMPARATOR

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

Interventions

Hypotonic Solution DRUG

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.

Intravenous hypotonic solution

Water Purified DRUG

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.

Enteral water

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients with hypernatremia (serum sodium\>145mEq/L).

You may not qualify if:

• Age below 18 years
• Pregnant, on dialysis
• Unwilling to participate or without informed consent.

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Related Publications (25)

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MeSH Terms

Conditions

Hypernatremia

Interventions

Hypotonic Solutions

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations

Study Officials

• Jonathan Samuel Chavez Iñiguez

  HCG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Samuel Chavez Iñiguez

CONTACT

3313299609; jonarchi_10@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of nephrology Dr. Jonathan Samuel Chavez Iñiguez

Model Details: Open Label randomized trial

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 29, 2023
• Study Start: November 30, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09