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

A Multi Center Observational Study on the Effects of Maintenance Fluids on Overall Fluid Balance in ICU Patients.

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.

Study Overview

• Status: Completed
• Conditions: Fluid Therapy; Fluid Overload; Critical Care

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	One week
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.	One week

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No