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

Critical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972475
• Other study ID #: 2018/
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: April 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Critical Care
• Fluid Overload
• Fluid Therapy

Locations

Country	Name	City	State
Sweden	ICU, Mälarsjukhuset Eskilstuna	Eskilstuna
Sweden	ICU, Gävle Hospital	Gävle
Sweden	ICU, Sahlgrenska University Hospital	Gothenburg
Sweden	ICU, Karolinska Hospital Huddinge	Huddinge	Stockholm
Sweden	ICU, Karolinska hospital Solna	Solna	Stockholm
Sweden	Central ICU (CIVA), Uppsal university hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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