Fluid OverloadNCT03972475
The Effect of Maintenance Fluids on Overall Fluid Balance in ICU Patients
An observational study of Fluid Overload and Fluid Therapy, run by Uppsala University at 6 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Fluid Therapy, Critical Care
- How many people
- 200 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Jan 2018to 15 Apr 2020
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
ICU, Mälarsjukhuset Eskilstuna
Eskilstuna, 63188
ICU, Gävle Hospital
Gävle, 80324
ICU, Sahlgrenska University Hospital
Gothenburg, 41345
ICU, Karolinska Hospital Huddinge
Huddinge, Stockholm County, 14157
ICU, Karolinska hospital Solna
Solna, Stockholm County, 17176
Central ICU (CIVA), Uppsal university hospital
Uppsala, 75185
About this study
Official title: 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.
Read the 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.
- Conditions
- Fluid Overload, Fluid Therapy, Critical Care
- Medical subject headings
- Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week
Secondary outcomes (2)
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).
Measured: 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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miklos Lipcsey, Assoc prof, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972475
- Sponsor's protocol ID
- 2018
- Status last verified
- Apr 2020
- First submitted
- 24 May 2019
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35330925Nihlen 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.
PubMed 33074941
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Observational Study on the Effects of Maintenance Fluids on Overall Fluid Balance in ICU Patients.
- ClinicalTrials.gov ID
- NCT03972475
- Acronym / sponsor ID
- 2018
- Conditions
- Fluid Overload, Fluid Therapy, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluid balance
Time frame: 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.
2 secondary outcomes
Fluid needs vs actual fluids given
Time frame: One week
Electrolyte
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 35330925Nihlen 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.
- Derived from this study: PubMed 33074941Nihlen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklos Lipcsey, Assoc prof study director
Uppsala University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Overload and Fluid Therapy, run by Uppsala University at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid balance (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972475, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.