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CompletedNCT03752450HYPNICUpdated Apr 12, 2019

Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit

An observational study in Hypernatremia, sponsored by Catharina Ziekenhuis Eindhoven. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-12.

Sponsored by Catharina Ziekenhuis Eindhoven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

Read the detailed description

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. The main mechanism is an imbalance between sodium and total body water. Consequently, this poses multiple factors to play a role in the development of hypernatremia. multifactorial. Previous studies focused on predictors in the development of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that correction of hypernatremia can reduce the associated mortality risk.

This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

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Conditions studied

  • Hypernatremia

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Keywords

  • Water-electrolyte imbalance
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

As a cardiothoracic and oncologic center, the ICU in the Catharina Hospital mostly admits postoperative patients. Other categories of admission are sepsis, respiratory insufficiency, intoxication. However, all patients with an indication for hemodynamic, respiratory of metabolic monitoring will be admitted. The Catharina Hospital is a tertiairy referral hospital. The ICU has 32 beds.

Inclusion criteria

  • Adults >17 years old
  • Admitted >48 hours in ICU

Exclusion criteria

Exclusion Criteria:

  • Expected discharge same day as day of inclusion
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU patients

    All patients admitted to ICU \>48 hours will be included. Eventually, a number of these patients will develop hypernatremia and form the cases. The patients who will not develop hypernatremia will be assigned as the controls.

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What researchers measure

Primary outcomes

  1. Development of hypernatremia

    Serum sodium levels \>145mmol/L

    Time frame: During ICU admission

  2. Recovery of hypernatremia

    Serum sodium levels returning back to levels below 146mmol/L

    Time frame: During ICU admission

Secondary outcomes

  1. Mortality

    Patient did or did not pass away.

    Time frame: During ICU admission as well as during hospital admission

  2. Length of stay

    Number of days of admission

    Time frame: Admission in ICU as well as in hospital

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Study locations

1 site
  • Catharina Hospital Eindhoven
    Eindhoven, Noord-Brabant 5623 EJ, Netherlands
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References and documents

Publications

  • Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29. PubMed 23369520 ↗
  • Lindner G, Funk GC, Lassnigg A, Mouhieddine M, Ahmad SA, Schwarz C, Hiesmayr M. Intensive care-acquired hypernatremia after major cardiothoracic surgery is associated with increased mortality. Intensive Care Med. 2010 Oct;36(10):1718-1723. doi: 10.1007/s00134-010-1968-4. Epub 2010 Jul 24. PubMed 20658124 ↗
  • Marshall DC, Salciccioli JD, Goodson RJ, Pimentel MA, Sun KY, Celi LA, Shalhoub J. The association between sodium fluctuations and mortality in surgical patients requiring intensive care. J Crit Care. 2017 Aug;40:63-68. doi: 10.1016/j.jcrc.2017.02.012. Epub 2017 Feb 13. PubMed 28347943 ↗
  • Bihari S, Festa M, Peake SL, Seppelt IM, Williams P, Wilkins B, Bersten A. Sodium administration in critically ill paediatric patients in Australia and New Zealand: a multicentre point prevalence study. Crit Care Resusc. 2014 Jun;16(2):112-8. PubMed 24888281 ↗
  • Stelfox HT, Ahmed SB, Zygun D, Khandwala F, Laupland K. Characterization of intensive care unit acquired hyponatremia and hypernatremia following cardiac surgery. Can J Anaesth. 2010 Jul;57(7):650-8. doi: 10.1007/s12630-010-9309-1. Epub 2010 Apr 20. PubMed 20405264 ↗

Individual participant data

Plan to share: Undecided — If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.

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Registry details

Key details

Study ID
NCT03752450
Lead sponsor
Catharina Ziekenhuis Eindhoven
Responsible party
Eveline Mestrom (Doctor of Medicine, Principal Investigator, Catharina Ziekenhuis Eindhoven) — Principal investigator
First posted
Nov 26, 2018
Start date
May 25, 2018
Primary completion
Dec 20, 2018
Completion
Apr 10, 2019
Last update
Apr 12, 2019

Study contacts

Eveline Mestrom, MD
principal investigator · Catharina Ziekenhuis Eindhoven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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