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

NCT ID: NCT03752450

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-25

Study Completion Date

2019-04-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypernatremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults \>17 years old
* Admitted \>48 hours in ICU

Exclusion Criteria

\- Expected discharge same day as day of inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Eveline Mestrom

Doctor of Medicine, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eveline Mestrom, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

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Catharina Hospital Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 23369520 (View on PubMed)

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.

Reference Type RESULT
PMID: 20658124 (View on PubMed)

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.

Reference Type RESULT
PMID: 28347943 (View on PubMed)

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.

Reference Type RESULT
PMID: 24888281 (View on PubMed)

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.

Reference Type RESULT
PMID: 20405264 (View on PubMed)

Other Identifiers

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HYPNIC

Identifier Type: -

Identifier Source: org_study_id

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