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

Completed

• Conditions: Fluid Therapy; Critical Care; Fluid Overload

• Registration Number: NCT03972475
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Primary Completion: 2019-12-31
• Status Verified: 2020-04
• Study Completion: 2020-04-15
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.

Trial Locations

Locations (6)

ICU, Karolinska Hospital Huddinge; 🇸🇪 Huddinge, Stockholm, Sweden

ICU, Karolinska hospital Solna; 🇸🇪 Solna, Stockholm, Sweden

ICU, Mälarsjukhuset Eskilstuna; 🇸🇪 Eskilstuna, Sweden

ICU, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

ICU, Gävle Hospital; 🇸🇪 Gävle, Sweden

Central ICU (CIVA), Uppsal university hospital; 🇸🇪 Uppsala, Sweden