CClinicalTrials.gg
CompletedNCT03972475Updated Apr 29, 2020

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

An observational study in Fluid Overload, Fluid Therapy and Critical Care, sponsored by Uppsala University. Completed at 6 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Uppsala University · Observational

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

Read the 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.

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Conditions studied

  • Fluid Overload
  • Fluid Therapy
  • Critical Care
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In context

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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

All patients that spend one week or more in the general ICUs at the included hospitals. Data will be collected from day 3 of the ICU stay until day 7.

Eligibility criteria

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

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (actual)
Target follow-up
90 Days
Patient registry
Yes
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. Fluid balance

    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.

    Time frame: One week

Secondary outcomes

  1. Fluid needs vs actual fluids given

    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).

    Time frame: One week

  2. Electrolyte

    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.

    Time frame: One week

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Study locations

6 sites
  • ICU, Karolinska Hospital Huddinge
    Huddinge, Stockholm 14157, Sweden
  • ICU, Karolinska hospital Solna
    Solna, Stockholm 17176, Sweden
  • ICU, Mälarsjukhuset Eskilstuna
    Eskilstuna, 63188, Sweden
  • ICU, Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
  • ICU, Gävle Hospital
    Gävle, 80324, Sweden
  • Central ICU (CIVA), Uppsal university hospital
    Uppsala, 75185, Sweden
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References and documents

Publications

  • Nihlen S, Frithiof R, Titze J, Kawati R, Rasmusson J, Rylander C, Pikwer A, Castegren M, Belin A, Hultstrom M, Lipcsey M. The Contribution of Plasma Urea to Total Osmolality During Iatrogenic Fluid Reduction in Critically Ill Patients. Function (Oxf). 2021 Oct 29;3(1):zqab055. doi: 10.1093/function/zqab055. eCollection 2022. PubMed 35330925 ↗
  • Nihlen S, Kawati R, Rasmusson J, Rylander C, Pikwer A, Castegren M, Belin A, Lipcsey M. Hidden sources of fluids, sodium and potassium in stabilised Swedish ICU patients: A multicentre retrospective observational study. Eur J Anaesthesiol. 2021 Jun 1;38(6):625-633. doi: 10.1097/EJA.0000000000001354. PubMed 33074941 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03972475
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Jun 3, 2019
Start date
Jan 1, 2018
Primary completion
Dec 31, 2019
Completion
Apr 15, 2020
Last update
Apr 29, 2020

Study contacts

Miklos Lipcsey, Assoc prof
study director · Uppsala University

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 2020. You cannot join it, but the record below documents what was studied.

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