Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

September 25, 2023 updated by: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara

Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous hypotonic solution

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

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.
Placebo Comparator: Enteral water
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
Time Frame: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: the first 5 days of the study
the first 5 days of the study
renal function
Time Frame: the first 5 days of the study
serum creatinine
the first 5 days of the study
volume overload
Time Frame: the first 5 days of the study
volume overload determined by accumulated water balance in milliliters
the first 5 days of the study
neurological alterations
Time Frame: the first 5 days of the study
neurological disorders defined as the presence of altered state of consciousness, seizures and/or cerebral edema
the first 5 days of the study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
hyperglycemia, glucose >180mg/dL
Time Frame: the first 5 days of the study
hyperglycemia defined as capillary glucose >180mg/dL
the first 5 days of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Investigators

  • Principal Investigator: Jonathan Samuel Chavez Iñiguez, HCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Correction of hypernatremia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypernatremia

Clinical Trials on Hypotonic Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe