Shock CirculatoryNCT06729268
Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit
An observational study of Shock Circulatory and Heart Failure, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
Trial summary
The goal of this observational study is to investigate the prevalence of conditions allowing the performance fluid responsiveness tests in critically ill patients during admission to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock Circulatory, Heart Failure, Hypovolemia
- How many people
- 389 participants
- Where
- 1 sitePoland
- Study dates
- 3 Apr 2023to 27 May 2024
- 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: Adult patients admitted to the intensive care unit
Who may be able to join
- 1. Adult patients admitted to the intensive care unit
Who cannot join
- Age under 18
- The researcher unavailable in the intensive care unit
- Patient assessment cannot be completed within the first six hours after admission to the ICU
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, 45-401
About this study
Official title: Possibility of Applying Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit - a Prospective Observational Study.
The goal of this observational study is to investigate the prevalence of conditions allowing the performance fluid responsiveness tests in critically ill patients during admission to the intensive care unit.
Read the detailed description
Patients admitted to the intensive care unit are very often hemodynamically unstable. In these cases fluid responsiveness tests should be performed to assess whether the patient would benefit from the fluid administration.
However, fluid responsiveness tests have many limitations including lack of spontaneous breathing, necessity of invasive mechanical ventilation with tidal volume of > 8 mL/kg ideal body weight, regular hearth rhythm, and lack of abdominal hypertension.
In the study, the investigators evaluated the prevalence of conditions enabling the performance fluid responsiveness tests in patients admitted to the intensive care unit. An assessment was performed within the six hours after admission to the intensive care unit. Evaluation was based on transthoracic echocardiography, clinical examination of the patients, and data derived from anamnesis.
The following fluid responsiveness tests were included into assessment: passive leg raising test, end-expiratory occlusion test, pulse pressure variation, stroke volume variation, velocity time integral variation in left ventricle output track, tidal volume challenge, inferior vena cava diameter variation, and superior vena cava diameter variation.
The aim of the study was to assess how many patients have the conditions allowing performance fluid responsiveness tests during admission to the intensive care unit.
- Conditions
- Shock Circulatory, Heart Failure, Hypovolemia
- Medical subject headings
- Shock, Heart Failure, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated in the intensive care unit | Patients treated in the intensive care unit during the first six hours after admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.
The primary aim of the study is to assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.
Measured: Six hours after admission to the intensive care unit
Secondary outcomes (2)
To assess which fluid responsiveness test based on heart-lung interactions can be applied most often during admission to the intensive care unit
The secondary aim of the study is to assess which fluid responsiveness test based on heart-lung interaction can be applied most often during admission to the intensive care unit
Measured: Six hours after admission to the intensive care unit
To assess the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit
Secondary aim include an assessment the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit.
Measured: Six hours from the admission to the intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start3 Apr 2023
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock CirculatoryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryszard Gawda, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729268
- Sponsor's protocol ID
- PossFluRespTests
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possibility of Applying Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit - a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06729268
- Acronym / sponsor ID
- PossFluRespTests
- Conditions
- Shock Circulatory, Heart Failure, Hypovolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 11 Dec 2024 (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 goal of this observational study is to investigate the prevalence of conditions allowing the performance fluid responsiveness tests in critically ill patients during admission to the intensive care unit.
Detailed description
Patients admitted to the intensive care unit are very often hemodynamically unstable. In these cases fluid responsiveness tests should be performed to assess whether the patient would benefit from the fluid administration.
However, fluid responsiveness tests have many limitations including lack of spontaneous breathing, necessity of invasive mechanical ventilation with tidal volume of > 8 mL/kg ideal body weight, regular hearth rhythm, and lack of abdominal hypertension.
In the study, the investigators evaluated the prevalence of conditions enabling the performance fluid responsiveness tests in patients admitted to the intensive care unit. An assessment was performed within the six hours after admission to the intensive care unit. Evaluation was based on transthoracic echocardiography, clinical examination of the patients, and data derived from anamnesis.
The following fluid responsiveness tests were included into assessment: passive leg raising test, end-expiratory occlusion test, pulse pressure variation, stroke volume variation, velocity time integral variation in left ventricle output track, tidal volume challenge, inferior vena cava diameter variation, and superior vena cava diameter variation.
The aim of the study was to assess how many patients have the conditions allowing performance fluid responsiveness tests during admission to the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated in the intensive care unit | – | –Patients treated in the intensive care unit during the first six hours after admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit
Key inclusion criteria (1 listed)
- 1. Adult patients admitted to the intensive care unit
Key exclusion criteria (3 listed)
- Age under 18
- The researcher unavailable in the intensive care unit
- Patient assessment cannot be completed within the first six hours after admission to the ICU
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
To assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.
Time frame: Six hours after admission to the intensive care unit
The primary aim of the study is to assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.
2 secondary outcomes
To assess which fluid responsiveness test based on heart-lung interactions can be applied most often during admission to the intensive care unit
Time frame: Six hours after admission to the intensive care unit
To assess the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit
Time frame: Six hours from the admission to the intensive care unit.
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 31 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock Circulatory and Heart Failure, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
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 1 inclusion and 3 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
To assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit. (time frame: Six hours after admission to the intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.