Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit (HYPNIC)
10. april 2019 opdateret af: Eveline Mestrom, Catharina Ziekenhuis Eindhoven
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Noord-Brabant
-
Eindhoven, Noord-Brabant, Holland, 5623 EJ
- Catharina Hospital Eindhoven
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- Adults >17 years old
- Admitted >48 hours in ICU
Exclusion Criteria:
- Expected discharge same day as day of inclusion
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Development of hypernatremia
Tidsramme: During ICU admission
|
Serum sodium levels >145mmol/L
|
During ICU admission
|
|
Recovery of hypernatremia
Tidsramme: During ICU admission
|
Serum sodium levels returning back to levels below 146mmol/L
|
During ICU admission
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: During ICU admission as well as during hospital admission
|
Patient did or did not pass away.
|
During ICU admission as well as during hospital admission
|
|
Length of stay
Tidsramme: Admission in ICU as well as in hospital
|
Number of days of admission
|
Admission in ICU as well as in hospital
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Eveline Mestrom, MD, Catharina Ziekenhuis Eindhoven
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. maj 2018
Primær færdiggørelse (Faktiske)
20. december 2018
Studieafslutning (Faktiske)
10. april 2019
Datoer for studieregistrering
Først indsendt
21. november 2018
Først indsendt, der opfyldte QC-kriterier
21. november 2018
Først opslået (Faktiske)
26. november 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HYPNIC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .