Clinical trial NCT03972475: The Effect of Maintenance Fluids on Overall Fluid Balance in ICU Patients
Official title: A Multi Center Observational Study on the Effects of Maintenance Fluids on Overall Fluid Balance in ICU Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Overload
Fluid Therapy
Critical Care
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

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

Exclusion Criteria:

-

Primary outcomes:
measure: Fluid balance
timeFrame: One week
Secondary outcomes:
measure: Fluid needs vs actual fluids given
timeFrame: One week
measure: Electrolyte
timeFrame: One week
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: ICU, Karolinska Hospital Huddinge
state: Stockholm
city: Solna
country: Sweden
facility: ICU, Karolinska hospital Solna
state: Stockholm
city: Eskilstuna
country: Sweden
facility: ICU, Mälarsjukhuset Eskilstuna
city: Gothenburg
country: Sweden
facility: ICU, Sahlgrenska University Hospital
city: Gävle
country: Sweden
facility: ICU, Gävle Hospital
city: Uppsala
country: Sweden
facility: Central ICU (CIVA), Uppsal university hospital
Study officials:
affiliation: Uppsala University
name: Miklos Lipcsey, Assoc prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.