Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit (HYPNIC)

Insight in the Development and Recovery of Hypernatremia in Critically Ill Patients.

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.

Study Overview

• Status: Completed
• Conditions: Hypernatremia

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Hospital Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Expected discharge same day as day of inclusion

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of hypernatremia	Serum sodium levels >145mmol/L	During ICU admission
Recovery of hypernatremia	Serum sodium levels returning back to levels below 146mmol/L	During ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patient did or did not pass away.	During ICU admission as well as during hospital admission
Length of stay	Number of days of admission	Admission in ICU as well as in hospital

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Eveline Mestrom, MD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Water-electrolyte imbalance
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hypernatremia
• Other Study ID Numbers: HYPNIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No