The Effect of Maintenance Fluids on Overall Fluid Balance in ICU Patients

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT03972475
Collaborator
(none)
200
6
27.4
33.3
1.2

Study Details

Study Description

Brief Summary

The amount of fluids characterized as non-resuscitation fluids given to ICU patients are likely to be high and will probably have a substantial impact on the total amount of fluid administered to ICU patients daily. It will most likely also influence on the total fluid balance and the negative outcome of fluid overload.

The aim of our study is to investigate the amount of fluid given as maintenance fluids in the ICU and the impact of this fluid on total fluid balance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Fluid therapy is an important part in both prevention and treatment of shock and multiple organ dysfunction in the ICU. However, the risks of giving patients too much fluids resulting in fluid has been gaining increased focus during recent years. Numerous studies regarding the amount of resuscitation fluid given to ICU patients have been performed, as well as investigations regarding factors that trigger the decision to deliver a fluid challenge to the patients. Likewise, multiple studies reveal that a more restrictive use of resuscitation fluids often lead to a better outcome for our patients.

    However, data regarding the amount of maintenance fluids and the effect of maintenance fluids on fluid balance and consequently outcome remain sparse. One major difficulty is that there is no universal definition of the term maintenance fluid. Some researchers include all fluids that is not considered resuscitation fluids, i.e. fluids given to administer drugs, to keep peripheral and central venous catheters functioning, administration of basal fluid needs and nutrition, while others exclude fluids covering basal needs and nutrition from the definition.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Multi Center Observational Study on the Effects of Maintenance Fluids on Overall Fluid Balance in ICU Patients.
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Apr 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Fluid balance [One week]

      To register the volume of fluid given to ICU patients categorized as resuscitation fluid, fluid to cover basal needs and nutrition and as fluid given to administer drugs and keeping intravenous accesses functioning. This will be measured i milliliters of fluid that the patients receive intravenously and orally by studying patient charts manually from their stay in the ICU.

    Secondary Outcome Measures

    1. Fluid needs vs actual fluids given [One week]

      To relate the quantity of maintenance fluid given to the patients with their theoretical fluid needs, by counting their needs (basal need of 30 mls/kg/day, previous losses and ongoing losses) and comparing it to the amount of fluid that the patient has actually received (by going through patient charts from their ICU stay).

    2. Electrolyte [One week]

      Total amount of electrolytes given to the patients intravenously or orally in the study, measured in mmol, by manually going through charts from patients ICU-stay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: All ICU patients that spent one week or more in the ICU. -

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICU, Karolinska Hospital Huddinge Huddinge Stockholm Sweden 14157
    2 ICU, Karolinska hospital Solna Solna Stockholm Sweden 17176
    3 ICU, Mälarsjukhuset Eskilstuna Eskilstuna Sweden 63188
    4 ICU, Sahlgrenska University Hospital Gothenburg Sweden 41345
    5 ICU, Gävle Hospital Gävle Sweden 80324
    6 Central ICU (CIVA), Uppsal university hospital Uppsala Sweden 75185

    Sponsors and Collaborators

    • Uppsala University

    Investigators

    • Study Director: Miklos Lipcsey, Assoc prof, Uppsala University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT03972475
    Other Study ID Numbers:
    • 2018/
    First Posted:
    Jun 3, 2019
    Last Update Posted:
    Apr 29, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 29, 2020