Critical IllnessRATIONALENCT04187534
Critical Care OptimizatIon of Albumin Ordering
A study testing Albumin Fluid Resuscitation Optimization Intervention and Usual Practice in people with Critical Illness, run by University of Calgary at 15 sites in Canada.
Trial summary
Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Albumin Fluid Resuscitation Optimization Intervention and Usual Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 15 sitesCanada
- Study dates
- 25 Nov 2019to 1 Nov 2022
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients admitted to the study ICUs
Who cannot join
- -
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Rockyview General Hospital
Calgary, Alberta, T2V 1P9
South Health Campus
Calgary, Alberta, T3M 1M4
Mazankowski Heart Institute
Edmonton, Alberta, T4N 4E7
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nun's Hospital
Edmonton, Alberta, T6L 5X8
Northern Lights Regional Health Centre
Fort McMurray, Alberta, T9H 1P2
Queen Elizabeth II Hospital
Grande Prairie, Alberta, T8V 2E8
Chinook Regional Hospital
Lethbridge, Alberta, T1J 1W5
Medicine Hat Regional Hospital
Medicine Hat, Alberta, T1A 4H6
Red Deer Regional Hospital Centre
Red Deer, Alberta, T4N 4E7
Sturgeon Community Hospital
St. Albert, Alberta, T8N 6C4
About this study
Official title: Critical Care Optimization of Albumin Ordering
Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported albumin use outside these circumstances as a quality improvement opportunity in Alberta ICUs. In 2017, the investigators began a pilot initiative to reduce albumin overuse in 6 ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework, and consisted of establishing a clinical champion, educating clinicians, changing the process for albumin ordering (albumin-specific order sheet), and providing quarterly audit/feedback data to clinicians on albumin utilization. During the intervention, there was a 41% relative reduction in albumin utilization. However, follow-up data identified problems with sustainability. These sustainability challenges combined with data suggesting high albumin use in other ICUs throughout Alberta have led the current project to build on the pilot initiative to reduce albumin overuse within all adult ICUs in Alberta.
The proposed quality improvement intervention will be implemented in 16 adult ICUs using a registry-based, stepped-wedge implementation design that will lean heavily on existing Provincial healthcare infrastructure. The intervention was developed using the Theoretical Domains Framework, and tailored to the unique features of each participating ICU. It will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period. To evaluate the quality improvement initiative, eCritical will serve as a 'registry' and will be used to capture all clinical and outcome data. The primary outcome will be the proportion of ICU admissions without an evidence-based indication for albumin, prescribed at least 1 unit of albumin (any concentration) during admission to ICU. 'Evidence-based indication' will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with spontaneous bacterial peritonitis or large volume ascitic fluid removal.
Read the detailed description
BACKGROUND: Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported overuse of albumin fluid resuscitation as a stakeholder-identified quality improvement opportunity in Alberta ICUs. Audit data from the provincial electronic medical record (EMR) for critical care, eCritical, reinforced stakeholder opinion and demonstrated that within Alberta ICUs in 2016 a considerable amount of albumin use deviated from evidence-based indications. On average, 14% of admissions to adult ICUs received at least one albumin unit during their ICU admission, with several high-use units providing albumin to between 20% and 35% of admissions. In 2017 the investigators began a pilot quality improvement initiative to reduce albumin overuse in six ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework. Questionnaires completed by clinicians working in the target ICU identified local culture and opinion of clinical leaders as barriers, and education, order sets, and clinical champions as facilitators to reducing albumin use. The intervention thus consisted of establishing a clinical champion, educating clinicians, changing the process for albumin through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization. There was a 41% reduction in albumin utilization, however follow-up data identified problems with sustainability. The current project will build on the pilot initiative to implement a quality improvement intervention to reduce albumin overuse within all adult ICUs in Alberta.
OBJECTIVE: Evaluate albumin reduction within all adult ICUs in Alberta.
METHODS: This will be a registry-based, stepped-wedge quality improvement initiative.
Quality Improvement Initiative: Spread to 16 adult ICUs in Alberta will require understanding and adapting the investigators pilot intervention to local barriers and facilitators. The intervention for this quality improvement initiative will be developed using the Theoretical Domains Framework. The research team will develop working groups responsible for tailoring the intervention and implementation strategy to each participating ICU. This will be conducted as part of the Province-wide quality improvement initiative. The investigators will conduct the quality improvement initiative using a registry-based, stepped-wedge, implementation trial. Owing to the nature of this design, the interventions will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period.
Registry-based data analysis: To evaluate this quality improvement initiative, the Provincial EMR for critical care, eCritical, will serve as a 'registry' and will be used to capture all clinical and outcome data. Data will be collected until patient death or hospital discharge and censored at 60 days. To optimize efficiency and power, data will be collected 3-months before and after implementation of the interventions.
SETTING: 16 adult ICUs in Alberta's critical care strategic clinical network reflecting teaching/non-teaching and urban/rural hospitals will participate.
STUDY POPULATION: All adult patients (>18 years) admitted to the study ICUs during the study period (November 2019 to January 2021). Study ICUs will include 14 general medical-surgical ICUs, and 2 cardiovascular surgery ICUs.
OUTCOMES: The primary outcome of this study will be the proportion of ICU patients without an evidence-based indication for albumin prescribed at least 1 unit of albumin (any concentration) during admission to ICU. Evidence-based indication will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with either spontaneous bacterial peritonitis or large volume ascitic fluid removal. This outcome was selected because: 1) there is precedent within current literature; 2) previous experience auditing albumin utilization in Alberta ICUs demonstrate it is available through eCritical; 3) it provides a relevant, broadly understandable estimate of the effect of the implementation science intervention to change albumin overuse; and 4) it permits assessment of the feasibility of implementing the platform to develop and carry out multi-stakeholder implementation science interventions to promote evidence-informed clinical practices and evaluate the intervention.
- Conditions
- Critical Illness
- Being tested
- Albumin Fluid Resuscitation Optimization Intervention, Usual Practice
- Keywords
- Albumin, fluid resuscitation, de-adoption, de-implementation, low-value care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin Fluid Resuscitation Optimization InterventionOther
Multi-faceted quality improvement intervention to optimize appropriateness of albumin use for fluid resuscitation
Usual PracticeOther
Albumin fluid resuscitation according to usual practice
| Study group | Role | What they receive |
|---|---|---|
| Albumin Fluid Resuscitation Optimization Intervention | Experimental | Our quality improvement intervention seeking to improve appropriate use and reduce inappropriate use of albumin for fluid resuscitation will consist of establishing a clinical champion, educating clinicians, changing the process for albumin ordering through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization. Receives: Other: Albumin Fluid Resuscitation Optimization Intervention |
| Usual Practice | Active comparator | Stepped-wedge roll out of 'Albumin Fluid Resuscitation Optimization Intervention' will permit those ICUs wherein intervention has not yet been implemented to serve as controls. These ICUs will prescribe albumin according to usual practice and not be exposed to any components of the intervention. Receives: Other: Usual Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ICU admissions receiving albumin
Proportion of ICU admissions without an evidence-based indication for albumin prescribed at least 1 unit of albumin (any concentration) during admission to ICU
Measured: During ICU admission
Secondary outcomes (9)
Mean number of albumin units among those receiving albumin
Mean number of albumin units prescribed to patients without an evidence-based indication for albumin that received at least 1 unit of albumin
Measured: During ICU admission
Total fluid administration
Total volume of fluid administered during days 1-7 in ICU
Measured: ICU day 7
Total crystalloid fluid
Total volume of crystalloid fluid administered during days 1-7 in ICU
Measured: ICU Day 7
Duration of vasopressor administration
Number of days vasopressors administered during ICU length of stay
Measured: From date of ICU admission to date of discharge, on average 1-6 days
Length of mechanical ventilation
Number of days on mechanical ventilation from time of starting mechanical ventilation during ICU length of stay
Measured: From date mechanical ventilation commended to date discontinued, on average 0-3 days
ICU length of stay
Number of days admitted to ICU (unique number per admission)
Measured: From date of ICU admission to date of discharge, on average 1-6 days
Hospital length of stay
Number of days admitted to hospital (unique number per admission)
Measured: From date of hospital admission to date of discharge, on average 5-20 days
ICU mortality
Survival to discharge from ICU
Measured: From date of ICU admission to date of discharge, on average 1-6 days
Hospital mortality
Survival to discharge from hospital
Measured: From date of hospital admission to date of discharge, on average 5-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start25 Nov 2019
- Primary completion21 Jan 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Registry-based, stepped-wedge, implementation trial
- Masking
- None (open label)
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Daniel Niven, University of Calgary
- Investigators
- Daniel J Niven, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187534
- Sponsor's protocol ID
- 19-1143
- Acronym
- RATIONALE
- Status last verified
- Oct 2022
- First submitted
- 26 Nov 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sauro K, Bagshaw SM, Niven D, Soo A, Brundin-Mather R, Parsons Leigh J, Cook DJ, Stelfox HT. Barriers and facilitators to adopting high value practices and de-adopting low value practices in Canadian intensive care units: a multimethod study. BMJ Open. 2019 Mar 15;9(3):e024159. doi: 10.1136/bmjopen-2018-024159.
PubMed 30878979
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Care Optimization of Albumin Ordering
- ClinicalTrials.gov ID
- NCT04187534
- Acronym / sponsor ID
- RATIONALE / 19-1143
- Conditions
- Critical Illness
- Keywords
- Albumin, fluid resuscitation, de-adoption, de-implementation, low-value care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 5 Dec 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.
Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported albumin use outside these circumstances as a quality improvement opportunity in Alberta ICUs. In 2017, the investigators began a pilot initiative to reduce albumin overuse in 6 ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework, and consisted of establishing a clinical champion, educating clinicians, changing the process for albumin ordering (albumin-specific order sheet), and providing quarterly audit/feedback data to clinicians on albumin utilization. During the intervention, there was a 41% relative reduction in albumin utilization. However, follow-up data identified problems with sustainability. These sustainability challenges combined with data suggesting high albumin use in other ICUs throughout Alberta have led the current project to build on the pilot initiative to reduce albumin overuse within all adult ICUs in Alberta.
The proposed quality improvement intervention will be implemented in 16 adult ICUs using a registry-based, stepped-wedge implementation design that will lean heavily on existing Provincial healthcare infrastructure. The intervention was developed using the Theoretical Domains Framework, and tailored to the unique features of each participating ICU. It will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period. To evaluate the quality improvement initiative, eCritical will serve as a 'registry' and will be used to capture all clinical and outcome data. The primary outcome will be the proportion of ICU admissions without an evidence-based indication for albumin, prescribed at least 1 unit of albumin (any concentration) during admission to ICU. 'Evidence-based indication' will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with spontaneous bacterial peritonitis or large volume ascitic fluid removal.
Detailed description
BACKGROUND: Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported overuse of albumin fluid resuscitation as a stakeholder-identified quality improvement opportunity in Alberta ICUs. Audit data from the provincial electronic medical record (EMR) for critical care, eCritical, reinforced stakeholder opinion and demonstrated that within Alberta ICUs in 2016 a considerable amount of albumin use deviated from evidence-based indications. On average, 14% of admissions to adult ICUs received at least one albumin unit during their ICU admission, with several high-use units providing albumin to between 20% and 35% of admissions. In 2017 the investigators began a pilot quality improvement initiative to reduce albumin overuse in six ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework. Questionnaires completed by clinicians working in the target ICU identified local culture and opinion of clinical leaders as barriers, and education, order sets, and clinical champions as facilitators to reducing albumin use. The intervention thus consisted of establishing a clinical champion, educating clinicians, changing the process for albumin through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization. There was a 41% reduction in albumin utilization, however follow-up data identified problems with sustainability. The current project will build on the pilot initiative to implement a quality improvement intervention to reduce albumin overuse within all adult ICUs in Alberta.
OBJECTIVE: Evaluate albumin reduction within all adult ICUs in Alberta.
METHODS: This will be a registry-based, stepped-wedge quality improvement initiative.
Quality Improvement Initiative: Spread to 16 adult ICUs in Alberta will require understanding and adapting the investigators pilot intervention to local barriers and facilitators. The intervention for this quality improvement initiative will be developed using the Theoretical Domains Framework. The research team will develop working groups responsible for tailoring the intervention and implementation strategy to each participating ICU. This will be conducted as part of the Province-wide quality improvement initiative. The investigators will conduct the quality improvement initiative using a registry-based, stepped-wedge, implementation trial. Owing to the nature of this design, the interventions will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period.
Registry-based data analysis: To evaluate this quality improvement initiative, the Provincial EMR for critical care, eCritical, will serve as a 'registry' and will be used to capture all clinical and outcome data. Data will be collected until patient death or hospital discharge and censored at 60 days. To optimize efficiency and power, data will be collected 3-months before and after implementation of the interventions.
SETTING: 16 adult ICUs in Alberta's critical care strategic clinical network reflecting teaching/non-teaching and urban/rural hospitals will participate.
STUDY POPULATION: All adult patients (>18 years) admitted to the study ICUs during the study period (November 2019 to January 2021). Study ICUs will include 14 general medical-surgical ICUs, and 2 cardiovascular surgery ICUs.
OUTCOMES: The primary outcome of this study will be the proportion of ICU patients without an evidence-based indication for albumin prescribed at least 1 unit of albumin (any concentration) during admission to ICU. Evidence-based indication will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with either spontaneous bacterial peritonitis or large volume ascitic fluid removal. This outcome was selected because: 1) there is precedent within current literature; 2) previous experience auditing albumin utilization in Alberta ICUs demonstrate it is available through eCritical; 3) it provides a relevant, broadly understandable estimate of the effect of the implementation science intervention to change albumin overuse; and 4) it permits assessment of the feasibility of implementing the platform to develop and carry out multi-stakeholder implementation science interventions to promote evidence-informed clinical practices and evaluate the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Registry-based, stepped-wedge, implementation trial
| Arm | Type | Receives |
|---|---|---|
| Albumin Fluid Resuscitation Optimization Intervention | Experimental | Other: Albumin Fluid Resuscitation Optimization InterventionOur quality improvement intervention seeking to improve appropriate use and reduce inappropriate use of albumin for fluid resuscitation will consist of establishing a clinical champion, educating clinicians, changing the process for albumin ordering through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization. |
| Usual Practice | Active comparator | Other: Usual PracticeStepped-wedge roll out of 'Albumin Fluid Resuscitation Optimization Intervention' will permit those ICUs wherein intervention has not yet been implemented to serve as controls. These ICUs will prescribe albumin according to usual practice and not be exposed to any components of the intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients admitted to the study ICUs
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin Fluid Resuscitation Optimization InterventionMulti-faceted quality improvement intervention to optimize appropriateness of albumin use for fluid resuscitation | Other | Albumin Fluid Resuscitation Optimization Intervention |
| Usual PracticeAlbumin fluid resuscitation according to usual practice | Other | Usual Practice |
Primary outcome
Proportion of ICU admissions receiving albumin
Time frame: During ICU admission
Proportion of ICU admissions without an evidence-based indication for albumin prescribed at least 1 unit of albumin (any concentration) during admission to ICU
9 secondary outcomes
Mean number of albumin units among those receiving albumin
Time frame: During ICU admission
Total fluid administration
Time frame: ICU day 7
Total crystalloid fluid
Time frame: ICU Day 7
Duration of vasopressor administration
Time frame: From date of ICU admission to date of discharge, on average 1-6 days
Length of mechanical ventilation
Time frame: From date mechanical ventilation commended to date discontinued, on average 0-3 days
ICU length of stay
Time frame: From date of ICU admission to date of discharge, on average 1-6 days
Hospital length of stay
Time frame: From date of hospital admission to date of discharge, on average 5-20 days
ICU mortality
Time frame: From date of ICU admission to date of discharge, on average 1-6 days
Hospital mortality
Time frame: From date of hospital admission to date of discharge, on average 5-20 days
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 2 Nov 2022.
- Results publication: PubMed 30878979Sauro K, Bagshaw SM, Niven D, Soo A, Brundin-Mather R, Parsons Leigh J, Cook DJ, Stelfox HT. Barriers and facilitators to adopting high value practices and de-adopting low value practices in Canadian intensive care units: a multimethod study. BMJ Open. 2019 Mar 15;9(3):e024159. doi: 10.1136/bmjopen-2018-024159.
- 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.
Daniel J Niven, MD, PhD principal investigator
University of Calgary
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin Fluid Resuscitation Optimization Intervention and Usual Practice in people with Critical Illness, run by University of Calgary at 15 sites in Canada.
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 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. 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?
Proportion of ICU admissions receiving albumin (time frame: During ICU admission). 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 NCT04187534, which also lists 1 linked publication.
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 2 Nov 2022.