NCT03972475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

May 24, 2019

Last Update Submit

April 28, 2020

Conditions

Outcome Measures

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.

    One week

Secondary Outcomes (2)

  • Fluid needs vs actual fluids given

    One week

  • Electrolyte

    One week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

ICU, Karolinska Hospital Huddinge

Huddinge, Stockholm County, 14157, Sweden

Location

ICU, Karolinska hospital Solna

Solna, Stockholm County, 17176, Sweden

Location

ICU, Mälarsjukhuset Eskilstuna

Eskilstuna, 63188, Sweden

Location

ICU, Gävle Hospital

Gävle, 80324, Sweden

Location

ICU, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Central ICU (CIVA), Uppsal university hospital

Uppsala, 75185, Sweden

Location

Related Publications (2)

  • 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.

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Miklos Lipcsey, Assoc prof

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

June 3, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

April 15, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations